AccessGUDID - DEVICE: Ascension® First Choice® DRUJ System (10381780123552)

GUDID

Device Identifier (DI) Information

Brand Name: Ascension® First Choice® DRUJ System
Version or Model: DRUJ6101455WW
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DRUJ6101455WW
Company Name: Ascension Orthopedics, Inc.

Primary DI Number: 10381780123552
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2026
Device Count: 1
Labeler D-U-N-S® Number*: 942377524 *Terms of Use

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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
33720	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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KXE	PROSTHESIS, WRIST, HEMI-, ULNAR

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K112481	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 14.5 mm head; 5.5 mm stem

Device Record Status

Public Device Record Key: 2aa3bf0b-a9d0-4ecf-9e9b-ec0f8595530c
Public Version Date: February 22, 2023
Public Version Number: 5
DI Record Publish Date: October 09, 2017