AccessGUDID - DEVICE: Universal 2™ Total Wrist System (10381780065906)

GUDID

Device Identifier (DI) Information

Brand Name: Universal 2™ Total Wrist System
Version or Model: 261201
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 261201
Company Name: Ascension Orthopedics, Inc.

Primary DI Number: 10381780065906
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 Universal 2 Total Wrist carpal component is a titanium ‘plate’ which is fixed into the carpal bones with a cemented central peg and two titanium screws.

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?
33705	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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
JWJ	Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K030037	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
Special Storage Condition, Specify: Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 24.7 mm dia x 24 mm L; Size Small

Device Record Status

Public Device Record Key: cb562d4a-c154-4eaa-afc2-adfac8c99d30
Public Version Date: February 21, 2023
Public Version Number: 7
DI Record Publish Date: October 09, 2017