AccessGUDID - DEVICE: Ascension® Silicone MCP (10381780114390)

GUDID

Device Identifier (DI) Information

Brand Name: Ascension® Silicone MCP
Version or Model: SMCP50020WW
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SMCP-500-20-WW
Company Name: Ascension Orthopedics, Inc.

Primary DI Number: 10381780114390
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: One-piece, flexible hinge, anatomically designed, silicone MCP prosthesis designed to be implanted without bone cement across the metacarpophalangeal joint.

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
KYJ	PROSTHESIS, FINGER, CONSTRAINED, POLYMER

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K022892	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: Size 20

Device Record Status

Public Device Record Key: 26859db9-f7d9-43ab-9212-d2bf5315b530
Public Version Date: February 23, 2023
Public Version Number: 7
DI Record Publish Date: October 09, 2017