Home GUDID 10381780234951 Integra® First Choice®
Primary DI 10381780234951
Brand Integra® First Choice®
Company Ascension Orthopedics, Inc.
Model FRSTDRUJINSP
Device description The Integra First Choice DRUJ System is intended for replacement of the distal radio-ulnar joint for rheumatoid, degenerative, or post traumatic arthritis. The set includes head and stem trials to evaluate the size and fit of the appropriate implant. Instruments are also included to assist with the trials.
Published 2016-08-15
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx 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 10381780234951 Primary GS1 0 M268FRSTDRUJINSP1 Secondary HIBCC 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10381780234951 10381780234951
GMDN Terms# Term, Definition table Term Definition General external orthopaedic fixation system implantation kit, reusable A collection of mostly instruments intended to be used to manipulate and prepare soft-tissue and bone for the adjustment or placement of the implantable components of an external orthopaedic fixation system in various skeletal areas (e.g., bones of limbs, spine, pelvis, craniomaxillofacial areas). It is a non-dedicated device that includes various metallic and/or plastic reusable devices (e.g., retractors, rods, clamps, drills, pins, cutters, screwdrivers, guides, tighteners) that are specific to the fixation system applied; the implant(s) is not included. This is a reusable device.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 942377524 Device count 1 Kit true Serial number true Sterilization required before use 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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