Home GUDID M268348002E1 Integra® Freedom Wrist Arthroplasty System
Primary DI M268348002E1
Brand Integra® Freedom Wrist Arthroplasty System
Company INTEGRA LIFESCIENCES CORPORATION
Model 348002E
Catalog number 348002E
Device description The Integra Freedom Wrist Arthroplasty carpal plate is used in an assembly with the carpal implant, and is fixed into the carpal bones with a central peg and two screws and locking caps.
Published 2017-10-09
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name JWJ Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class JWJ Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10381780066798 Primary GS1 0 M268348002E1 Secondary HIBCC 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10381780066798 10381780066798
GMDN Terms# Term, Definition table Term Definition Total wrist prosthesis A sterile implantable artificial substitute for a wrist joint designed to replace both articulating surfaces of the damaged (e.g., fractured) and/or degenerative (e.g., arthritic) joint. It includes radial and carpal components, usually with an intervening ball/spacer, with parts made of metal and polyethylene (PE). Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.
Regulatory Flags# DUNS number 963856096 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00885556854839 Freedom Wrist Arthroplasty System Smith & Nephew, Inc. JWJ 2022-12-22 00885556854846 Freedom Wrist Arthroplasty System Smith & Nephew, Inc. JWJ 2022-12-22 00885556854853 Freedom Wrist Arthroplasty System Smith & Nephew, Inc. JWJ 2022-12-22 00885556855249 Freedom Wrist Arthroplasty System Smith & Nephew, Inc. JWJ 2022-12-22 00885556855256 Freedom Wrist Arthroplasty System Smith & Nephew, Inc. JWJ 2022-12-22 00885556855263 Freedom Wrist Arthroplasty System Smith & Nephew, Inc. JWJ 2022-12-22 00885556855270 Freedom Wrist Arthroplasty System Smith & Nephew, Inc. JWJ 2022-12-22 00885556855287 Freedom Wrist Arthroplasty System Smith & Nephew, Inc. JWJ 2022-12-22 00885556855294 Freedom Wrist Arthroplasty System Smith & Nephew, Inc. JWJ 2022-12-22 00885556855553 Freedom Wrist Arthroplasty System Smith & Nephew, Inc. JWJ 2022-12-22 00885556855560 Freedom Wrist Arthroplasty System Smith & Nephew, Inc. JWJ 2022-12-22 00885556855577 Freedom Wrist Arthroplasty System Smith & Nephew, Inc. JWJ 2022-12-22 00885556855584 Freedom Wrist Arthroplasty System Smith & Nephew, Inc. JWJ 2022-12-22 00885556855591 Freedom Wrist Arthroplasty System Smith & Nephew, Inc. JWJ 2022-12-22 00885556855607 Freedom Wrist Arthroplasty System Smith & Nephew, Inc. JWJ 2022-12-22 00885556855614 Freedom Wrist Arthroplasty System Smith & Nephew, Inc. JWJ 2022-12-22 00885556855621 Freedom Wrist Arthroplasty System Smith & Nephew, Inc. JWJ 2022-12-22 00885556855638 Freedom Wrist Arthroplasty System Smith & Nephew, Inc. JWJ 2022-12-22 00885556855669 Freedom Wrist Arthroplasty System Smith & Nephew, Inc. JWJ 2022-12-22 00885556855676 Freedom Wrist Arthroplasty System Smith & Nephew, Inc. JWJ 2022-12-22 00885556855683 Freedom Wrist Arthroplasty System Smith & Nephew, Inc. JWJ 2022-12-22 00885556855690 Freedom Wrist Arthroplasty System Smith & Nephew, Inc. JWJ 2022-12-22 00885556855706 Freedom Wrist Arthroplasty System Smith & Nephew, Inc. JWJ 2022-12-22 00885556855713 Freedom Wrist Arthroplasty System Smith & Nephew, Inc. JWJ 2022-12-22 00885556855720 Freedom Wrist Arthroplasty System Smith & Nephew, Inc. JWJ 2022-12-22 00885556855737 Freedom Wrist Arthroplasty System Smith & Nephew, Inc. JWJ 2022-12-22 00885556855744 Freedom Wrist Arthroplasty System Smith & Nephew, Inc. JWJ 2022-12-22 00885556855751 Freedom Wrist Arthroplasty System Smith & Nephew, Inc. JWJ 2022-12-22 00885556855768 Freedom Wrist Arthroplasty System Smith & Nephew, Inc. JWJ 2022-12-22 00885556855775 Freedom Wrist Arthroplasty System Smith & Nephew, Inc. JWJ 2022-12-22
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