Home GUDID B013DRUJIS450 NA
Primary DI B013DRUJIS450
Brand NA
Company APTIS MEDICAL, LLC
Model DRUJ-IS450
Catalog number DRUJ-IS450
Device description Distal Radio-Ulnar Joint Stem, 4 cm Extended, 5.0 mm Diameter
Published 2015-06-02
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
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 B013DRUJIS450 Primary HIBCC 0
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.
Sterilization Methods# Method table Method Ethylene Oxide
Regulatory Flags# DUNS number 780455338 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 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