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
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
Stone/foreign-body extraction setStone/foreign-body extraction setClass IIa
Endoscopic electrosurgical handpiece/electrode bipolar single-useEndoscopic electrosurgical handpiece/electrode bipolar single-useClass IIa
Flexible endoscopic scissors reusableFlexible endoscopic scissors reusableClass IIa
Ureteral catheterUreteral catheterClass IIa
Gastrointestinal/biliary dilation balloon catheterGastrointestinal/biliary dilation balloon catheterClass IIa
Surgical instrument guard reusableSurgical instrument guard reusableClass IIb
Intravenous/irrigation solution storage container single-useIntravenous/irrigation solution storage container single-useClass IIb
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
Pneumatic/ultrasonic lithotripsy systemPneumatic/ultrasonic lithotripsy systemClass IIa
Vacuum hoseVacuum hoseClass 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
Electrosurgical system generatorElectrosurgical system generatorClass IIa
Tympanotomy knife bladeTympanotomy knife bladeClass IIb
Preformed vocal cord medialization implantPreformed vocal cord medialization implantClass IIa
Electrocautery system electrodeElectrocautery system electrodeClass IIa
Electrosurgical handpiece single-useElectrosurgical handpiece single-useClass IIa
General/multiple surgical solid-state laser systemGeneral/multiple surgical solid-state laser systemClass IIa
General/multiple surgical laser system beam guide single-useGeneral/multiple surgical laser system beam guide single-useClass IIa
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 IIa
General-purpose surgical suction system electricGeneral-purpose surgical suction system electricClass IIb
Medical ruler reusableMedical ruler reusableClass IIa
Polymeric ureteral stentPolymeric ureteral stentClass IIa
Metal/carbide ENT bur single-useMetal/carbide ENT bur single-useClass IIb
Polyethylene craniofacial tissue reconstructive materialPolyethylene craniofacial tissue reconstructive materialClass IIa
Tympanostomy tubeTympanostomy tubeClass IIb
Endoscope sheath reusableEndoscope sheath reusableClass IIb
Ossicular prosthesis partialOssicular prosthesis partialClass IIb
Intranasal splint non-bioabsorbable animal-derivedIntranasal splint non-bioabsorbable animal-derivedClass IIa
Surgical torque wrench reusableSurgical torque wrench reusableClass IIa
External nasal splintExternal nasal splintClass IIb
Nasal haemostatic balloonNasal haemostatic balloonClass IIa
Device sterilization/disinfection container reusableDevice sterilization/disinfection container reusableClass IIa
Intranasal splint non-biodegradableIntranasal splint non-biodegradableClass IIb
Self-retaining ear speculumSelf-retaining ear speculumClass IIa
Fibreoptic light cableFibreoptic light cableClass IIb
General-purpose curetteGeneral-purpose curetteClass IIa
Ear wick non-biodegradableEar wick non-biodegradableClass IIb
Patient surgical drape single-usePatient surgical drape single-useClass IIa
Electrical-only medical device connection cable reusableElectrical-only medical device connection cable reusableClass IIb
Laparoscopic access cannula seal reducerLaparoscopic access cannula seal reducerClass III
Intranasal splint biodegradableIntranasal splint biodegradableClass I
Instrument tray reusableInstrument tray reusableClass I
Surgical instrument/endoscope cleaning utensil reusableSurgical instrument/endoscope cleaning utensil reusableClass I
Medical video image recorderMedical video image recorderClass I
Endoscopic guidewire holderEndoscopic guidewire holderClass I
Endobronchial airway sizing kitEndobronchial airway sizing kitClass I
Endobronchial valveEndobronchial valveClass I
Endobronchial valve delivery catheterEndobronchial valve delivery catheterClass I
Endobronchial valve delivery catheterEndobronchial valve delivery catheterClass I
Endobronchial valve delivery catheterEndobronchial valve delivery catheterClass I
Endobronchial valve delivery catheterEndobronchial valve delivery catheterClass I
Endobronchial valve delivery catheterEndobronchial valve delivery catheterClass I
Endobronchial valve delivery catheterEndobronchial valve delivery catheterClass I
Endobronchial valve delivery catheterEndobronchial valve delivery catheterClass I
Endobronchial valve delivery catheterEndobronchial valve delivery catheter
Endobronchial valve delivery catheterEndobronchial valve delivery catheterClass I
Endobronchial valve delivery catheterEndobronchial valve delivery catheterClass I
Endobronchial valve delivery catheterEndobronchial valve delivery catheterClass I
Endobronchial valve delivery catheterEndobronchial valve delivery catheterClass I
Endobronchial valve delivery catheterEndobronchial valve delivery catheterClass I
Endobronchial valve delivery catheterEndobronchial valve delivery catheterClass I
Endobronchial valve delivery catheterEndobronchial valve delivery catheterClass I
Endobronchial valve delivery catheterEndobronchial valve delivery catheterClass I
Endobronchial valve delivery catheterEndobronchial valve delivery catheterClass I
Endobronchial valve delivery catheterEndobronchial valve delivery catheterClass I
Endobronchial valve delivery catheterEndobronchial valve delivery catheterClass I
Endobronchial valve delivery catheterEndobronchial valve delivery catheterClass I
Endobronchial valve delivery catheterEndobronchial valve delivery catheterClass I
Endobronchial valve delivery catheterEndobronchial valve delivery catheterClass I
Endobronchial valve delivery catheterEndobronchial valve delivery catheterClass I
Endobronchial valve delivery catheterEndobronchial valve delivery catheterClass I
Endobronchial valve delivery catheterEndobronchial valve delivery catheterClass I
Endobronchial valve delivery catheterEndobronchial valve delivery catheterClass I
Endobronchial valve delivery catheterEndobronchial valve delivery catheterClass I
Endobronchial valve delivery catheterEndobronchial valve delivery catheterClass IIb
Endobronchial valve delivery catheterEndobronchial valve delivery catheterClass I
Endobronchial valve delivery catheterEndobronchial valve delivery catheterClass I
Endobronchial valve delivery catheterEndobronchial valve delivery catheterClass IIb
Endobronchial valve delivery catheterEndobronchial valve delivery catheterClass IIb