Manufacturer's Devices - Gyrus ACMI Inc.

Address:




9600 Louisiana Ave.



North Brooklyn Park

MN 55445

United States


Authorised Representative/ UK Responsible Person
Name: KeyMed (Medical & Industrial Equipment) Ltd.
Address:

Keymed House Stock Road



Southend-on-sea

Essex SS2 5QH

United Kingdom




Code/Term Type
ENT shaver systemENT shaver systemClass IIa
ENT shaver systemENT shaver systemClass IIa
Manual scalpel blade single-useManual scalpel blade single-useClass IIa
Manual scalpel blade single-useManual scalpel blade single-useClass IIa
Endoscopic-access dilator single-useEndoscopic-access dilator single-useClass IIa
Arthroscopic shaver system handpiece pneumaticArthroscopic shaver system handpiece pneumaticClass IIa
Arthroscopic shaver system handpiece pneumaticArthroscopic shaver system handpiece pneumaticClass IIa
Arthroscopic shaver system handpiece pneumaticArthroscopic shaver system handpiece pneumaticClass IIa
Stone/foreign-body extraction setStone/foreign-body extraction setClass IIa
Endoscopic electrosurgical handpiece/electrode bipolar single-useEndoscopic electrosurgical handpiece/electrode bipolar single-useClass IIb
Flexible endoscopic scissors reusableFlexible endoscopic scissors reusableClass IIb
Ureteral catheterUreteral catheterClass IIa
Gastrointestinal/biliary dilation balloon catheterGastrointestinal/biliary dilation balloon catheterClass IIa
Surgical instrument guard reusableSurgical instrument guard reusableClass IIa
Intravenous/irrigation solution storage container single-useIntravenous/irrigation solution storage container single-useClass IIa
ENT suction dissectorENT suction dissectorClass IIa
Tissue extraction bagTissue extraction bagClass IIa
Surgical irrigation/aspiration tubing setSurgical irrigation/aspiration tubing setClass IIa
Nasal implant synthetic polymer non-bioabsorbableNasal implant synthetic polymer non-bioabsorbableClass IIa
Fascial tissue dilator reusableFascial tissue dilator reusableClass IIa
Foot-switch electricalFoot-switch electricalClass IIa
Ureteropelvic balloon catheterUreteropelvic balloon catheterClass IIa
ENT surgical procedure kit non-medicated single-useENT surgical procedure kit non-medicated single-useClass IIa
Ultrasonic lithotripsy system handpieceUltrasonic lithotripsy system handpieceClass IIa
Surgical irrigation/aspiration pump reusableSurgical irrigation/aspiration pump reusableClass IIa
Surgical irrigation/aspiration pump reusableSurgical irrigation/aspiration pump reusableClass IIa
Surgical irrigation/aspiration pump reusableSurgical irrigation/aspiration pump reusableClass IIa
Pneumatic/ultrasonic lithotripsy systemPneumatic/ultrasonic lithotripsy systemClass IIb
Vacuum hoseVacuum hoseClass IIa
Orthopaedic bur reusableOrthopaedic bur reusableClass IIa
Orthopaedic bur reusableOrthopaedic bur reusableClass IIa
Surgical fluid/smoke waste management system suction unitSurgical fluid/smoke waste management system suction unitClass IIa
Burring power tool attachmentBurring power tool attachmentClass IIa
Burring power tool attachmentBurring power tool attachmentClass IIa
Electrosurgical system generatorElectrosurgical system generatorClass IIa
Tympanotomy knife bladeTympanotomy knife bladeClass IIa
Preformed vocal cord medialization implantPreformed vocal cord medialization implantClass IIb
Electrocautery system electrodeElectrocautery system electrodeClass IIa
Electrocautery system electrodeElectrocautery system electrodeClass IIa
Electrosurgical handpiece single-useElectrosurgical handpiece single-useClass IIb
Orthopaedic bur reusableOrthopaedic bur reusableClass IIa
General/multiple surgical solid-state laser systemGeneral/multiple surgical solid-state laser systemClass IIb
General/multiple surgical laser system beam guide single-useGeneral/multiple surgical laser system beam guide single-useClass IIb
Endoscopic electrosurgical handpiece/electrode bipolar single-useEndoscopic electrosurgical handpiece/electrode bipolar single-useClass IIb
Body aspiration needle single-useBody aspiration needle single-useClass IIa
Gastro-urological guidewire single-useGastro-urological guidewire single-useClass IIa
Endoscopic electrosurgical electrode monopolar single-useEndoscopic electrosurgical electrode monopolar single-useClass IIb
General-purpose surgical suction system electricGeneral-purpose surgical suction system electricClass IIa
Medical ruler reusableMedical ruler reusableClass IIa
Polymeric ureteral stentPolymeric ureteral stentClass IIb
Metal/carbide ENT bur single-useMetal/carbide ENT bur single-useClass IIa
Polyethylene craniofacial tissue reconstructive materialPolyethylene craniofacial tissue reconstructive materialClass IIb
Metal/carbide ENT bur single-useMetal/carbide ENT bur single-useClass IIa
Tympanostomy tubeTympanostomy tubeClass IIb
Endoscope sheath reusableEndoscope sheath reusableClass IIa
Ossicular prosthesis partialOssicular prosthesis partialClass IIb
Intranasal splint non-bioabsorbable animal-derivedIntranasal splint non-bioabsorbable animal-derivedClass III
Pneumatic/ultrasonic lithotripsy systemPneumatic/ultrasonic lithotripsy systemClass I
Surgical torque wrench reusableSurgical torque wrench reusableClass I
External nasal splintExternal nasal splintClass I
Nasal haemostatic balloonNasal haemostatic balloonClass I
Sterilization/disinfection container reusableSterilization/disinfection container reusableClass I
Intranasal splint non-biodegradableIntranasal splint non-biodegradableClass I
Tympanostomy tubeTympanostomy tubeClass I
Self-retaining ear speculumSelf-retaining ear speculumClass I
Fibreoptic light cableFibreoptic light cableClass I
Ossicular prosthesis partialOssicular prosthesis partialClass I
Body aspiration needle single-useBody aspiration needle single-useClass I
Orthopaedic bur reusableOrthopaedic bur reusableClass I
Manual scalpel blade single-useManual scalpel blade single-useClass I
General-purpose curetteGeneral-purpose curetteClass I
Laparoscopic access cannula seal reducerLaparoscopic access cannula seal reducerClass I
General/multiple surgical solid-state laser systemGeneral/multiple surgical solid-state laser system
Ear wick non-biodegradableEar wick non-biodegradableClass I
Ultrasonic lithotripsy system handpieceUltrasonic lithotripsy system handpieceClass I
Patient surgical drape single-usePatient surgical drape single-useClass I
Electrical-only medical device connection cable reusableElectrical-only medical device connection cable reusableClass I
Laparoscopic access cannula seal reducerLaparoscopic access cannula seal reducerClass I
Intranasal splint biodegradableIntranasal splint biodegradableClass I
Intranasal splint biodegradableIntranasal splint biodegradableClass I
Instrument tray reusableInstrument tray reusableClass I
Surgical instrument/endoscope cleaning utensil reusableSurgical instrument/endoscope cleaning utensil reusableClass I
Foot-switch electricalFoot-switch electricalClass I
Gastro-urological guidewire single-useGastro-urological guidewire single-useClass I
Pneumatic/ultrasonic lithotripsy systemPneumatic/ultrasonic lithotripsy systemClass I
Surgical irrigation/aspiration tubing setSurgical irrigation/aspiration tubing setClass I
General-purpose surgical suction system electricGeneral-purpose surgical suction system electricClass I
Medical video image recorderMedical video image recorderClass I
Endoscopic guidewire holderEndoscopic guidewire holderClass I
General/multiple surgical solid-state laser systemGeneral/multiple surgical solid-state laser systemClass I
ENT shaver systemENT shaver systemClass I
Surgical irrigation/aspiration tubing setSurgical irrigation/aspiration tubing setClass I
Endoscopic electrosurgical handpiece/electrode bipolar single-useEndoscopic electrosurgical handpiece/electrode bipolar single-useClass IIb