Home GUDID 10381780123637 Ascension® First Choice® DRUJ System
Primary DI 10381780123637
Brand Ascension® First Choice® DRUJ System
Company Ascension Orthopedics, Inc.
Model DRUJ6101945WW
Catalog number DRUJ6101945WW
Device description The Ascensions First Choice DRUJ System is an anatomically designed, semi-constrained, distal ulnar head replacement. It has a distal articular head and proximal intramedullary stem. The cobalt chromium implant head articulates with the radius and the carpal bones of the wrist. These features match native ulnar head articulation. The implant is inserted into the medullary canal of the ulna following resection of the ulnar head. It is designed to be a press fit device that achieves fixation by means of direct implant/bone appositions.
Published 2017-10-09
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name KXE PROSTHESIS, WRIST, HEMI-, ULNAR
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KXE Prosthesis, Wrist, Hemi-, Ulnar Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10381780123637 Primary GS1 0 M268DRUJ6101945WW1 Secondary HIBCC 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10381780123637 10381780123637
GMDN Terms# Term, Definition table Term Definition Wrist ulna-head prosthesis A sterile implantable device designed to replace the distal ulnar head of the radio-ulnar joint following ulnar head resection typically due to arthritis, post-traumatic disabilities (pain, weakness, instability), or failed alternative treatment. It may be a one-piece or modular device made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel] and/or 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
Regulatory Flags# DUNS number 942377524 Device count 1 Lot or batch true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00885556826621 First Choice DRUJ and MUH Smith & Nephew, Inc. KXE 2023-06-16 00885556826461 First Choice Partial Ulnar Head Implant Smith & Nephew, Inc. KXE 2022-12-21 00885556826478 First Choice Partial Ulnar Head Implant Smith & Nephew, Inc. KXE 2022-12-21 00885556826485 First Choice Partial Ulnar Head Implant Smith & Nephew, Inc. KXE 2022-12-21 00885556826492 First Choice Partial Ulnar Head Implant Smith & Nephew, Inc. KXE 2022-12-21 00885556826508 First Choice Partial Ulnar Head Implant Smith & Nephew, Inc. KXE 2022-12-21 00885556826515 First Choice Partial Ulnar Head Implant Smith & Nephew, Inc. KXE 2022-12-21 00885556826522 First Choice Partial Ulnar Head Implant Smith & Nephew, Inc. KXE 2022-12-21 00885556826539 First Choice Partial Ulnar Head Implant Smith & Nephew, Inc. KXE 2022-12-21 00885556826546 First Choice Partial Ulnar Head Implant Smith & Nephew, Inc. KXE 2022-12-21 00885556826553 First Choice Partial Ulnar Head Implant Smith & Nephew, Inc. KXE 2022-12-21 00885556826560 First Choice Partial Ulnar Head Implant Smith & Nephew, Inc. KXE 2022-12-21 00885556826577 First Choice Partial Ulnar Head Implant Smith & Nephew, Inc. KXE 2022-12-21 00885556826584 First Choice Modular Ulnar Head Implant Smith & Nephew, Inc. KXE 2022-12-21 00885556826591 First Choice Modular Ulnar Head Implant Smith & Nephew, Inc. KXE 2022-12-21 00885556826607 First Choice Modular Ulnar Head Implant Smith & Nephew, Inc. KXE 2022-12-21 00885556826614 First Choice Modular Ulnar Head Implant Smith & Nephew, Inc. KXE 2022-12-21 00885556826195 First Choice Modular Ulnar Head Implant Smith & Nephew, Inc. KXE 2022-12-21 00885556826201 First Choice Modular Ulnar Head Implant Smith & Nephew, Inc. KXE 2022-12-21 00885556826218 First Choice Modular Ulnar Head Implant Smith & Nephew, Inc. KXE 2022-12-21 00885556826225 First Choice Modular Ulnar Head Implant Smith & Nephew, Inc. KXE 2022-12-21 00885556826232 First Choice Modular Ulnar Head Implant Smith & Nephew, Inc. KXE 2022-12-21 00885556826249 First Choice Modular Ulnar Head Implant Smith & Nephew, Inc. KXE 2022-12-21 00885556826256 First Choice Modular Ulnar Head Implant Smith & Nephew, Inc. KXE 2022-12-21 00885556826263 First Choice Modular Ulnar Head Implant Smith & Nephew, Inc. KXE 2022-12-21 00885556826270 First Choice Modular Ulnar Head Implant Smith & Nephew, Inc. KXE 2022-12-21 00885556826287 First Choice Modular Ulnar Head Implant Smith & Nephew, Inc. KXE 2022-12-21 00885556826294 First Choice Modular Ulnar Head Implant Smith & Nephew, Inc. KXE 2022-12-21 00885556826300 First Choice Modular Ulnar Head Implant Smith & Nephew, Inc. KXE 2022-12-21 B013DRUJB10200 NA APTIS MEDICAL, LLC KXE 2021-08-27
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