Manufacturer's Devices - Blue Belt Technologies Inc.

Address:




2905 Northwest Boulevard Suite 40



Plymouth

Minnesota 55441

United States


Authorised Representative/ UK Responsible Person
Name: T.J.Smith and Nephew Limited
Address:

101 Hessle Road



Hull

HU3 2BN

England United Kingdom




Code/Term Type
Orthopaedic prosthesis implantation positioning instrument reusableOrthopaedic prosthesis implantation positioning instrument reusableClass I
Surgical screwdriver reusableSurgical screwdriver reusableClass I
Optical surgical navigation device tracking system workstation mobileOptical surgical navigation device tracking system workstation mobileClass I
Portable computerPortable computerClass I
Image display unit colourImage display unit colourClass I
Instrument tray reusableInstrument tray reusableClass I
Robotic surgical systemRobotic surgical systemClass I
Bone file/rasp manual reusableBone file/rasp manual reusableClass I
Surgical drill guide reusableSurgical drill guide reusableClass I
Bone-coring punch reusableBone-coring punch reusableClass I
Orthopaedic implantation sleeve reusableOrthopaedic implantation sleeve reusableClass I
Orthopaedic implant aiming/guiding block reusableOrthopaedic implant aiming/guiding block reusableClass I
Hand-held surgical retractor reusableHand-held surgical retractor reusableClass I
Surgical instrument guard reusableSurgical instrument guard reusableClass I
Surgical torque wrench reusableSurgical torque wrench reusableClass I
Orthopaedic surgical procedure kit non-medicated reusableOrthopaedic surgical procedure kit non-medicated reusableClass I
Orthopaedic/craniofacial implantation planning softwareOrthopaedic/craniofacial implantation planning softwareClass I
Imaging lesion localization marker external single-useOrthopaedic prosthesis implantation positioning instrument reusable Conformity Assessment Certificate ExpiredClass I
Multi-purpose surgical power tool system line-poweredImaging lesion localization marker external single-use Conformity Assessment Certificate ExpiredClass I
Cranial bur single-useRobotic surgical system Conformity Assessment Certificate ExpiredClass IIa
Surgical irrigation/aspiration tubing setOrthopaedic surgical procedure kit non-medicated reusable Conformity Assessment Certificate ExpiredClass I
Surgical irrigation/aspiration tubing setMulti-purpose surgical power tool system line-powered Conformity Assessment Certificate ExpiredClass IIa
Surgical irrigation/aspiration tubing setCranial bur single-use Conformity Assessment Certificate ExpiredClass IIa
Surgical irrigation/aspiration tubing setSurgical irrigation/aspiration tubing set Conformity Assessment Certificate ExpiredClass IIa
Surgical irrigation/aspiration tubing setSurgical irrigation/aspiration tubing set Conformity Assessment Certificate ExpiredClass IIa
Surgical irrigation/aspiration tubing setSurgical irrigation/aspiration tubing set Conformity Assessment Certificate ExpiredClass IIa
Surgical irrigation/aspiration tubing setSurgical irrigation/aspiration tubing set Conformity Assessment Certificate ExpiredClass IIa