AccessGUDID - DEVICE: Ascension MCP Joint Replacement (00885556856819)

GUDID

Device Identifier (DI) Information

Brand Name: Ascension MCP Joint Replacement
Version or Model: MCP-110-05D-WW
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MCP-110-05D-WW
Company Name: Smith & Nephew, Inc.

Primary DI Number: 00885556856819
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 045483575 *Terms of Use

Device Description: MCP SZ. 05 DISTAL WW

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?
33786	Metacarpophalangeal joint prosthesis, one-piece	An implantable artificial substitute for the metacarpophalangeal (MCP) joint(s) of the hand (finger) which has been damaged by rheumatoid, degenerative, or traumatic arthritis. It consists of a single flexible across-the-joint component (one-piece) made from either a silicone elastomer or a combination of polypropylene and polyester materials. The flexible across-the-joint component may be covered with a silicone rubber sleeve.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NEG	Finger semi-constrained pyrolytic carbon uncemented prosthesis

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P000057	007

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: 078c0647-b365-4144-88cc-5f69f3859963
Public Version Date: September 07, 2023
Public Version Number: 2
DI Record Publish Date: December 22, 2022