AccessGUDID - DEVICE: Freedom Wrist Arthroplasty System (00885556854846)

GUDID

Device Identifier (DI) Information

Brand Name: Freedom Wrist Arthroplasty System
Version or Model: 348002
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 348002
Company Name: Smith & Nephew, Inc.

Primary DI Number: 00885556854846
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 045483575 *Terms of Use

Device Description: CARPAL PLATE. SIZE 2

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 [?]
K132250	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
No Device Sizes

Device Record Status

Public Device Record Key: 062d0d8d-ebc6-4459-8c8f-f57585cf0a51
Public Version Date: September 07, 2023
Public Version Number: 2
DI Record Publish Date: December 22, 2022