Uniglide Unicondylar Knee Prosthesis BC8A-1G01-000

GUDID 05055196908062

EM ROD WITH BUSH

CORIN LTD

Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable
Primary Device ID05055196908062
NIH Device Record Key05ef7d51-a619-42cd-b9c0-fd4cbbaeb0d7
Commercial Distribution StatusIn Commercial Distribution
Brand NameUniglide Unicondylar Knee Prosthesis
Version Model NumberBC8A-1G01-000
Catalog NumberBC8A-1G01-000
Company DUNS295437313
Company NameCORIN LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+441285659866
Emaillucinda.gerber@coringroup.com
Phone+441285659866
Emaillucinda.gerber@coringroup.com
Phone+441285659866
Emaillucinda.gerber@coringroup.com
Phone+441285659866
Emaillucinda.gerber@coringroup.com
Phone+441285659866
Emaillucinda.gerber@coringroup.com
Phone+441285659866
Emaillucinda.gerber@coringroup.com
Phone+441285659866
Emaillucinda.gerber@coringroup.com
Phone+441285659866
Emaillucinda.gerber@coringroup.com
Phone+441285659866
Emaillucinda.gerber@coringroup.com
Phone+441285659866
Emaillucinda.gerber@coringroup.com
Phone+441285659866
Emaillucinda.gerber@coringroup.com
Phone+441285659866
Emaillucinda.gerber@coringroup.com
Phone+441285659866
Emaillucinda.gerber@coringroup.com
Phone+441285659866
Emaillucinda.gerber@coringroup.com
Phone+441285659866
Emaillucinda.gerber@coringroup.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105055196908062 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRYPROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[05055196908062]

Moist Heat or Steam Sterilization

[05055196908062]

Moist Heat or Steam Sterilization

[05055196908062]

Moist Heat or Steam Sterilization

[05055196908062]

Moist Heat or Steam Sterilization

[05055196908062]

Moist Heat or Steam Sterilization

[05055196908062]

Moist Heat or Steam Sterilization

[05055196908062]

Moist Heat or Steam Sterilization

[05055196908062]

Moist Heat or Steam Sterilization

[05055196908062]

Moist Heat or Steam Sterilization

[05055196908062]

Moist Heat or Steam Sterilization

[05055196908062]

Moist Heat or Steam Sterilization

[05055196908062]

Moist Heat or Steam Sterilization

[05055196908062]

Moist Heat or Steam Sterilization

[05055196908062]

Moist Heat or Steam Sterilization

[05055196908062]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-08-17

On-Brand Devices [Uniglide Unicondylar Knee Prosthesis]

05055343821404AMC UNI FIXED TRIAL INTRODUCER FORCEPS
05055196940253REFERENCE GUIDE ARM
05055196914612DAILLABLE STYLUS
05055196914520UNIGLIDE TIBIAL FIXED KEEL PUNCH SIZE 7
05055196914513UNIGLIDE TIBIAL FIXED KEEL PUNCH SIZE 5
05055196914506UNIGLIDE TIBIAL FIXED KEEL PUNCH SIZE 3
05055196914452TIBIAL CUTTING BLOCK ASSEMBLY
05055196914445TIBIAL CUTTING BLOCK ASSEMBLY
05055196909205BURR TOOL
05055196909199STARTER REAMER
05055196909182UNIGLIDE FIXED TIBIA TRIAL SIZE 3 13MM
05055196909175UNIGLIDE FIXED TIBIA TRIAL SIZE 3 11 MM
05055196909168UNIGLIDE FIXED TIBIA TRIAL SIZE 3 9MM
05055196909151UNIGLIDE FIXED TIBIA TRIAL SIZE 3 -7MM
05055196909144UNIGLIDE FIXED TIBIA TRIAL SIZE 5-13MM
05055196909137UNIGLIDE FIXED TIBIA TRIAL SIZE 5 -11MM
05055196909120UNIGLIDE FIXED TIBIA TRIAL SIZE 5 -9 MM
05055196909113UNIGLIDE FIXED TIBIA TRIAL SIZE 5 -7 MM
05055196909106UNIGLIDE FIXED TIBIA TRIAL SIZE 7- 13MM
05055196909090UNIGLIDE FIXED TIBIA TRIAL SIZE7- 11MM
05055196909083UNIGLIDE FIXED TIBIA TRIAL SIZE 7 -9 MM
05055196909076UNIGLIDE FIXED TIBIA TRIAL SIZE 7- 7MM
05055196909014TIBIAL ALIGNMENT JIG
05055196909007SPHERICAL REAMER- 14 MM SPANNER
05055196908994SPERICAL REAMER-12MM SPANNER
05055196908956FEMORAL DRILL 5 MM
05055196908949FEMORAL DRILL 3MM
05055196908932FEMORAL TRIAL SIZE 4 WITH SLOT
05055196908925FEMORAL TRIAL SIZE 3 WITH SLOT
05055196908918FEMORAL TRIAL SIZE 2 WITH SLOT
05055196908901SPHERICAL REAMER- SIZE 4
05055196908895SPHERICAL REAMER- SIZE 3
05055196908888SPHERICAL REAMER- SIZE 2
05055196908871FEMORAL TOWER ALIGNMENT PIN
05055196908659UNIGLIDE FIXED TRIAL SIZE 5-13
05055196908642UNIGLIDE FIXED TRIAL SIZE 5-11
05055196908635UNIGLIDE FIXED TRIAL SIZE 5-9
05055196908628UNIGLIDE FIXED BEARING TRIAL SIZE 5-7
05055196908345FEMORAL SLOT PUNCH
05055196908338FEMORAL SIZER TEMPLATE- SIZES 3 & 4
05055196908321FEMORAL SIZER TEMPLATE SIZES 1 & 2
05055196908284TIBIAL FIXED TEMPLATE TRIAL SIZE 7
05055196908277TIBIAL FIXED TEMPLATE TRIAL SIZE 5
05055196908260TIBIAL FIXED TEMPLATE TRIAL SIZE 3
05055196908185SIZER & PLACEMENT GUIDE FOR TIBIAL BASE
05055196908123C-ARM IMPACTOR
05055196908116FEMORAL ALIGNMENT TOWER
05055196908109FEMORAL CUTTING BLOCK- SIZE 4
05055196908093FEMORAL CUTTING BLOCK- SIZE 3
05055196908086FEMORAL CUTTING BLOCK- SIZE 2
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