Manufacturer's Devices - Arthrex Inc

Address:

1370 Creekside Blvd

Naples

Florida 34108

United States

Authorised Representative/ UK Responsible Person
Name: Emergo Consulting (UK) Limited
Address:

Compass House Vision Park Histon c/o Cr360 – UL International

Cambridge

CB24 9BZ

England United Kingdom

Code/Term		Type
Centrifuge bucket/tube holder	Centrifuge bucket/tube holder	Class IIa
Apheresis system	Apheresis system	Class IIa
Bone marrow biopsy procedure kit	Bone marrow biopsy procedure kit	Class IIa
Battery box	Battery box	Class IIa
Surgical camera holder	Surgical camera holder	Class IIa
Decontamination floor mat reusable	Decontamination floor mat reusable	Class IIa
Endoscopic surgical probe	Endoscopic surgical probe	Class IIa
Portable/mobile rechargeable battery pack	Portable/mobile rechargeable battery pack	Class IIa
Fluted surgical drill bit single-use	Fluted surgical drill bit single-use	Class IIa
Drilling power tool attachment basic	Drilling power tool attachment basic	Class IIa
Surgical drill chuck key	Surgical drill chuck key	Class IIa
Blood centrifugation system containment kit	Blood centrifugation system containment kit	Class IIa
Electrical mains power cable	Electrical mains power cable	Class IIa
Bone marrow biopsy needle single-use	Bone marrow biopsy needle single-use	Class IIa
Surgical saw blade oscillating single-use	Surgical saw blade oscillating single-use	Class IIa
Haematological concentrate system preparation kit platelet concentration	Haematological concentrate system preparation kit platelet concentration	Class IIa
Haematological concentrate system preparation kit thrombin separation	Haematological concentrate system preparation kit thrombin separation	Class IIa
Surgical instrument handle non-torque-limiting	Surgical instrument handle non-torque-limiting	Class IIa
Bone graft funnel	Bone graft funnel	Class IIa
Arthroscopic obturator	Arthroscopic obturator	Class IIa
Surgical tissue/fluid collection bag non-sterile	Surgical tissue/fluid collection bag non-sterile	Class IIa
Orthopaedic surgery tissue debris collector reusable	Orthopaedic surgery tissue debris collector reusable	Class IIa
Laparoscopic trocar blade reusable	Laparoscopic trocar blade reusable	Class IIa
Frame/rail/pole device holder	Frame/rail/pole device holder	Class IIa
Surgical instrument handle grip	Surgical instrument handle grip	Class IIa
Arthroscopic irrigation/insufflation system	Arthroscopic irrigation/insufflation system	Class IIa
Surgical saw blade sagittal single-use	Surgical saw blade sagittal single-use	Class IIa
Surgical saw blade reciprocating single-use	Surgical saw blade reciprocating single-use	Class IIa
Surgical irrigation tubing set single-use	Surgical irrigation tubing set single-use	Class IIa
Arthroscopic surgical procedure kit non-medicated single-use	Arthroscopic surgical procedure kit non-medicated single-use	Class IIa
Tendon/ligament bone anchor non-bioabsorbable	Tendon/ligament bone anchor non-bioabsorbable	Class IIa
Decontamination floor mat single-use	Decontamination floor mat single-use	Class IIa
Foot-switch electrical	Foot-switch electrical	Class IIa
Surgical torque wrench reusable	Surgical torque wrench reusable	Class IIa
Endoscope sheath reusable	Endoscope sheath reusable	Class IIa
Rigid optical laparoscope	Rigid optical laparoscope	Class IIa
Rigid endoscope obturator	Rigid endoscope obturator	Class IIa
Endoscope video camera	Endoscope video camera	Class IIa
Arthroscopic shaver system blade single-use	Arthroscopic shaver system blade single-use	Class IIa
Rigid arthroscope reusable	Rigid arthroscope reusable	Class IIa
Arthroscopic shaver system handpiece electrically-powered	Arthroscopic shaver system handpiece electrically-powered	Class IIa
Bone-coring punch reusable	Bone-coring punch reusable	Class IIa
Orthopaedic trocar blade reusable	Orthopaedic trocar blade reusable	Class IIa
Orthopaedic surgical distractor internal	Orthopaedic surgical distractor internal	Class IIa
Suturing unit single-use	Suturing unit single-use	Class IIa
Cannulated surgical drill bit reusable	Cannulated surgical drill bit reusable	Class IIa
Scalpel handle reusable	Scalpel handle reusable	Class IIa
Medical equipment drape single-use	Medical equipment drape single-use	Class IIa
Orthopaedic implant inserter/extractor reusable	Orthopaedic implant inserter/extractor reusable	Class IIa
Orthopaedic osteotome	Orthopaedic osteotome	Class IIa
Orthopaedic prosthesis implantation positioning instrument reusable	Orthopaedic prosthesis implantation positioning instrument reusable	Class IIa
Bone trephine	Bone trephine	Class IIa
Bone tap reusable	Bone tap reusable	Class I
Fluted surgical drill bit reusable	Fluted surgical drill bit reusable	Class IIa
Surgical depth gauge reusable	Surgical depth gauge reusable	Class IIa
Orthopaedic bone pin non-bioabsorbable	Orthopaedic bone pin non-bioabsorbable	Class IIa
Orthopaedic implant impactor reusable	Orthopaedic implant impactor reusable	Class I
Orthopaedic bone screw starter/notcher	Orthopaedic bone screw starter/notcher	Class IIa
Orthopaedic implant driver	Orthopaedic implant driver	Class IIa
Surgical tamp reusable	Surgical tamp reusable	Class IIa
Bone hook	Bone hook	Class IIa
Surgical screwdriver reusable	Surgical screwdriver reusable	Class IIa
Bone approximation clamp	Bone approximation clamp	Class I
Bone lever/elevator reusable	Bone lever/elevator reusable	Class IIa
Surgical drill guide reusable	Surgical drill guide reusable	Class IIa
Medullary canal orthopaedic reamer flexible	Medullary canal orthopaedic reamer flexible	Class I
Tendon stripper	Tendon stripper	Class IIa
Bone file/rasp manual reusable	Bone file/rasp manual reusable	Class I
Orthopaedic bone wire	Orthopaedic bone wire	Class IIa
Orthopaedic casting stand	Orthopaedic casting stand	Class IIa
Arthroscopic access cannula single-use	Arthroscopic access cannula single-use	Class IIa
Surgical implant template single-use	Surgical implant template single-use	Class IIa
Cannulated surgical drill bit single-use	Cannulated surgical drill bit single-use	Class IIa
Bone-resection orthopaedic reamer single-use	Bone-resection orthopaedic reamer single-use	Class I
Osteotomy guide reusable	Osteotomy guide reusable	Class IIa
Arthroscopic access cannula seal single-use	Arthroscopic access cannula seal single-use	Class IIa
Wire/ligature passer single-use	Wire/ligature passer single-use	Class IIa
Instrument tray reusable	Instrument tray reusable	Class I
Dressing/utility forceps scissors-like reusable	Dressing/utility forceps scissors-like reusable	Class IIa
Device sterilization/disinfection container reusable	Device sterilization/disinfection container reusable	Class I
Bone awl reusable	Bone awl reusable	Class IIa
Suture cutter reusable	Suture cutter reusable	Class IIa
Surgical countersink reusable	Surgical countersink reusable	Class IIa
Bone curette reusable	Bone curette reusable	Class I
Wire cutter	Wire cutter	Class IIa
Surgical instrument guard reusable	Surgical instrument guard reusable	Class I
Adhesive bandage	Adhesive bandage	Class IIa
Rigid endoscopic tissue manipulation forceps reusable	Rigid endoscopic tissue manipulation forceps reusable	Class I
Chisel/osteotome blade handle	Chisel/osteotome blade handle	Class IIa
Orthopaedic cerclage applier	Orthopaedic cerclage applier	Class I
Body aspiration needle single-use	Body aspiration needle single-use	Class IIa
Orthopaedic broach	Orthopaedic broach	Class I
X-ray film magnifying glass	X-ray film magnifying glass	Class I
Orthopaedic operating table top	Orthopaedic operating table top	Class IIa
Manual scalpel blade single-use	Manual scalpel blade single-use	Class I
Crown surgical drill bit reusable	Crown surgical drill bit reusable	Class IIa
General-purpose surgical scissors reusable	General-purpose surgical scissors reusable	Class IIa
Endoscopic-access dilator single-use	Endoscopic-access dilator single-use	Class I
General-purpose surgical spatula	General-purpose surgical spatula	Class IIa
Electromechanical device/system transport trolley	Electromechanical device/system transport trolley	Class IIa
Surgical finger guard	Surgical finger guard	Class IIa
Surgical instrument/implant rack	Surgical instrument/implant rack	Class IIa
General internal orthopaedic fixation system implantation kit	General internal orthopaedic fixation system implantation kit	Class IIa
Manual orthopaedic bender reusable	Manual orthopaedic bender reusable	Class IIa
Medical ruler reusable	Medical ruler reusable	Class IIa
Limb/torso/head restraint single-use	Limb/torso/head restraint single-use	Class I
Suture knot pusher reusable	Suture knot pusher reusable	Class IIa
Surgical instrument handle torque-limiting	Surgical instrument handle torque-limiting	Class I
Surgical instrument torque limiter	Surgical instrument torque limiter	Class IIa
Surgical instrument/implant depth limiter	Surgical instrument/implant depth limiter	Class IIa
Orthopaedic fixation implant alignment tool	Orthopaedic fixation implant alignment tool	Class I
Orthopaedic knee/leg holder liner	Orthopaedic knee/leg holder liner	Class IIa
Tendon/ligament graft preparation station	Tendon/ligament graft preparation station	Class I
Surgical drill guide single-use	Surgical drill guide single-use	Class I
Patella prosthesis trial	Patella prosthesis trial	Class I
Humeral head prosthesis trial reusable	Humeral head prosthesis trial reusable	Class I
Surgical depth gauge single-use	Surgical depth gauge single-use	Class IIa
Orthopaedic prosthesis implantation positioning instrument single-use	Orthopaedic prosthesis implantation positioning instrument single-use	Class I
Knee arthroplasty force sensor balance kit	Knee arthroplasty force sensor balance kit	Class IIa
Orthopaedic implant/instrument assembling device	Orthopaedic implant/instrument assembling device	Class I
Bone access cannula	Bone access cannula	Class IIa
Reverse shoulder head prosthesis trial	Reverse shoulder head prosthesis trial	Class IIa
Shoulder glenoid fossa prosthesis trial	Shoulder glenoid fossa prosthesis trial	Class IIa
Humeral body prosthesis trial	Humeral body prosthesis trial	Class IIa
Humeral stem prosthesis trial reusable	Humeral stem prosthesis trial reusable	Class IIa
Reverse shoulder cup prosthesis trial reusable	Reverse shoulder cup prosthesis trial reusable	Class I
Humeral head spacer prosthesis trial	Humeral head spacer prosthesis trial	Class IIa
Shoulder reverse/standard adaptor prosthesis trial	Shoulder reverse/standard adaptor prosthesis trial	Class IIa
Suturing needle single-use	Suturing needle single-use	Class IIa
Surgical implant/trial-implant/sizer holder single-use	Surgical implant/trial-implant/sizer holder single-use	Class IIa
Cannulated surgical drill guiding pin	Cannulated surgical drill guiding pin	Class IIa
Arthroscopic access cannula reusable	Arthroscopic access cannula reusable	Class I
Orthopaedic osteotome blade single-use	Orthopaedic osteotome blade single-use	Class I
Low-pressure tubing connector single-use sterile	Low-pressure tubing connector single-use sterile	Class IIa
Cannulated surgical drill bit single-use non-sterile	Cannulated surgical drill bit single-use non-sterile	Class I
Orthopaedic implant inserter/extractor single-use	Orthopaedic implant inserter/extractor single-use	Class I
Surgical implant handling forceps	Surgical implant handling forceps	Class I
Glenoid defect sizer	Glenoid defect sizer	Class I
Reverse bone-resection orthopaedic reamer	Reverse bone-resection orthopaedic reamer	Class I
Orthopaedic bur reusable	Orthopaedic bur reusable	Class I
Dressing/utility forceps tweezers-like reusable	Dressing/utility forceps tweezers-like reusable	Class I
Surgical flat-nosed pliers	Surgical flat-nosed pliers	Class IIa
Electrical-only medical device connection cable reusable	Electrical-only medical device connection cable reusable	Class I
Tendon/ligament graft preparation station base	Tendon/ligament graft preparation station base	Class I
Tendon/ligament graft preparation station post	Tendon/ligament graft preparation station post	Class I
Leg procedure positioner	Leg procedure positioner	Class IIa
Orthopaedic implant-instrument extension adaptor reusable	Orthopaedic implant-instrument extension adaptor reusable	Class I
Bone tunnel plug non-cannulated	Bone tunnel plug non-cannulated	Class IIa
Arm procedure positioner reusable	Arm procedure positioner reusable	Class IIa
Endoscopic-access dilator reusable	Endoscopic-access dilator reusable	Class I
Orthopaedic osteotome blade reusable	Orthopaedic osteotome blade reusable	Class IIa
Bone/joint surgical power tool motorized handpiece/set electric reusable	Bone/joint surgical power tool motorized handpiece/set electric reusable	Class IIa
Orthopaedic bur single-use	Orthopaedic bur single-use	Class I
Soft-tissue surgical hook reusable	Soft-tissue surgical hook reusable	Class IIa
Sawing power tool attachment reciprocating	Sawing power tool attachment reciprocating	Class I
Orthopaedic surgical procedure kit non-medicated single-use	Orthopaedic surgical procedure kit non-medicated single-use	Class I
Orthopaedic graft inserter	Orthopaedic graft inserter	Class IIa
Orthopaedic graft tensioner reusable	Orthopaedic graft tensioner reusable	Class I
Orthopaedic graft guide	Orthopaedic graft guide	Class IIa
Orthopaedic reamer guide	Orthopaedic reamer guide	Class I
Bone-resection orthopaedic reamer reusable	Bone-resection orthopaedic reamer reusable	Class IIa
Suture knot pusher single-use	Suture knot pusher single-use	Class I
Hand-held surgical retractor reusable	Hand-held surgical retractor reusable	Class I
Orthopaedic implantation sleeve reusable	Orthopaedic implantation sleeve reusable	Class I
Bone tap single-use	Bone tap single-use	Class I
Joint prosthesis implantation kit reusable	Joint prosthesis implantation kit reusable	Class I
Arthroscopic shaver system electrically-powered	Arthroscopic shaver system electrically-powered	Class I
Orthopaedic implantable-device cutter	Orthopaedic implantable-device cutter	Class IIa
Surgical implant template reusable	Surgical implant template reusable	Class I
Surgical implant/trial-implant/sizer holder reusable	Surgical implant/trial-implant/sizer holder reusable	Class I
Orthopaedic implant aiming/guiding block reusable	Orthopaedic implant aiming/guiding block reusable	Class IIa
Knee femur prosthesis trial reusable	Knee femur prosthesis trial reusable	Class IIa
Knee tibia prosthesis trial reusable	Knee tibia prosthesis trial reusable	Class IIa
Suturing unit reusable	Suturing unit reusable	Class IIa
Suturing unit reusable	Suturing unit reusable	Class I
Suturing unit reusable	Suturing unit reusable	Class I
Suturing unit reusable	Suturing unit reusable	Class IIa
Suturing unit reusable	Suturing unit reusable	Class IIa
Suturing unit reusable	Suturing unit reusable	Class IIa
Suturing unit reusable	Suturing unit reusable	Class IIa
Suturing unit reusable	Suturing unit reusable	Class IIa
Suturing unit reusable	Suturing unit reusable	Class IIa
Suturing unit reusable	Suturing unit reusable	Class IIa
Suturing unit reusable	Suturing unit reusable	Class IIa
Suturing unit reusable	Suturing unit reusable	Class IIa
Suturing unit reusable	Suturing unit reusable	Class I
Suturing unit reusable	Suturing unit reusable	Class IIa
Suturing unit reusable	Suturing unit reusable	Class I
Suturing unit reusable	Suturing unit reusable	Class IIa
Suturing unit reusable	Suturing unit reusable	Class IIa
Suturing unit reusable	Suturing unit reusable	Class IIa
Suturing unit reusable	Suturing unit reusable	Class IIa
Suturing unit reusable	Suturing unit reusable	Class I
Suturing unit reusable	Suturing unit reusable	Class IIa
Suturing unit reusable	Suturing unit reusable	Class IIa
Suturing unit reusable	Suturing unit reusable	Class IIa
Suturing unit reusable	Suturing unit reusable	Class IIa
Suturing unit reusable	Suturing unit reusable	Class IIa
Suturing unit reusable	Suturing unit reusable	Class IIa
Suturing unit reusable	Suturing unit reusable	Class I
Suturing unit reusable	Suturing unit reusable	Class I
Suturing unit reusable	Suturing unit reusable	Class I
Suturing unit reusable	Suturing unit reusable	Class I
Suturing unit reusable	Suturing unit reusable	Class IIa
Suturing unit reusable	Suturing unit reusable	Class IIa
Suturing unit reusable	Suturing unit reusable	Class I
Suturing unit reusable	Suturing unit reusable	Class IIa
Suturing unit reusable	Suturing unit reusable	Class I
Suturing unit reusable	Suturing unit reusable	Class IIa
Suturing unit reusable	Suturing unit reusable	Class I
Suturing unit reusable	Suturing unit reusable	Class IIa
Suturing unit reusable	Suturing unit reusable	Class I
Suturing unit reusable	Suturing unit reusable	Class IIa
Suturing unit reusable	Suturing unit reusable	Class I
Suturing unit reusable	Suturing unit reusable	Class IIa
Suturing unit reusable	Suturing unit reusable	Class IIa
Suturing unit reusable	Suturing unit reusable	Class IIa
Suturing unit reusable	Suturing unit reusable	Class IIa
Suturing unit reusable	Suturing unit reusable	Class I
Suturing unit reusable	Suturing unit reusable	Class IIa
Suturing unit reusable	Suturing unit reusable	Class IIa
Suturing unit reusable	Suturing unit reusable	Class IIa
Suturing unit reusable	Suturing unit reusable	Class IIa
Suturing unit reusable	Suturing unit reusable	Class IIa
Suturing unit reusable	Suturing unit reusable	Class IIa
Suturing unit reusable	Suturing unit reusable	Class IIa
Suturing unit reusable	Suturing unit reusable	Class I
Suturing unit reusable	Suturing unit reusable	Class IIa
Suturing unit reusable	Suturing unit reusable	Class I
Suturing unit reusable	Suturing unit reusable	Class IIa
Suturing unit reusable	Suturing unit reusable	Class IIa
Suturing unit reusable	Suturing unit reusable	Class IIa
Suturing unit reusable	Suturing unit reusable	Class I
Suturing unit reusable	Suturing unit reusable	Class IIa
Suturing unit reusable	Suturing unit reusable	Class IIa
Suturing unit reusable	Suturing unit reusable	Class IIa
Suturing unit reusable	Suturing unit reusable	Class IIa
Suturing unit reusable	Suturing unit reusable	Class IIa
Suturing unit reusable	Suturing unit reusable	Class IIa
Suturing unit reusable	Suturing unit reusable	Class IIa
Suturing unit reusable	Suturing unit reusable	Class I
Suturing unit reusable	Suturing unit reusable	Class IIa
Suturing unit reusable	Suturing unit reusable	Class IIa
Suturing unit reusable	Suturing unit reusable	Class IIa
Suturing unit reusable	Suturing unit reusable	Class IIa
Suturing unit reusable	Suturing unit reusable	Class IIa
Suturing unit reusable	Suturing unit reusable	Class IIa
Suturing unit reusable	Suturing unit reusable	Class I
Suturing unit reusable	Suturing unit reusable	Class IIa
Suturing unit reusable	Suturing unit reusable	Class IIa
Suturing unit reusable	Suturing unit reusable	Class IIa
Suturing unit reusable	Suturing unit reusable	Class IIa
Suturing unit reusable	Suturing unit reusable	Class IIa
Suturing unit reusable	Suturing unit reusable	Class IIa
Suturing unit reusable	Suturing unit reusable	Class IIa
Suturing unit reusable	Suturing unit reusable	Class IIa
Suturing unit reusable	Suturing unit reusable	Class IIa
Suturing unit reusable	Suturing unit reusable	Class IIa
Suturing unit reusable	Suturing unit reusable	Class IIa
Suturing unit reusable	Suturing unit reusable	Class IIa
Suturing unit reusable	Suturing unit reusable	Class IIa
Suturing unit reusable	Suturing unit reusable	Class IIa
Suturing unit reusable	Suturing unit reusable	Class IIa
Suturing unit reusable	Suturing unit reusable	Class IIa
Suturing unit reusable	Suturing unit reusable	Class IIa
Suturing unit reusable	Suturing unit reusable	Class IIa
Suturing unit reusable	Suturing unit reusable	Class IIa
Suturing unit reusable	Suturing unit reusable	Class IIa
Suturing unit reusable	Suturing unit reusable	Class IIa
Suturing unit reusable	Suturing unit reusable	Class I
Suturing unit reusable	Suturing unit reusable	Class I
Suturing unit reusable	Suturing unit reusable	Class I
Suturing unit reusable	Suturing unit reusable	Class I
Suturing unit reusable	Suturing unit reusable	Class I
Suturing unit reusable	Suturing unit reusable	Class I
Suturing unit reusable	Suturing unit reusable	Class I
Suturing unit reusable	Suturing unit reusable	Class I
Suturing unit reusable	Suturing unit reusable	Class I
Suturing unit reusable	Suturing unit reusable	Class I
Suturing unit reusable	Suturing unit reusable	Class I
Suturing unit reusable	Suturing unit reusable	Class I
Suturing unit reusable	Suturing unit reusable	Class I
Suturing unit reusable	Suturing unit reusable	Class I
Suturing unit reusable	Suturing unit reusable	Class I
Suturing unit reusable	Suturing unit reusable	Class I
Suturing unit reusable	Suturing unit reusable	Class I
Suturing unit reusable	Suturing unit reusable	Class IIa

Manufacturer's Devices - Arthrex Inc

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