AccessGUDID - DEVICE: Ascension® MCP (10381780000402)

GUDID

Device Identifier (DI) Information

Brand Name: Ascension® MCP
Version or Model: MCP10030DWW
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MCP-100-30D-WW
Company Name: Ascension Orthopedics, Inc.

Primary DI Number: 10381780000402
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: Metacarpal-Phalangeal Joint Replacement Device

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: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Size: 30

Device Record Status

Public Device Record Key: 071ecf39-a955-479b-8201-21017bb2332d
Public Version Date: February 23, 2023
Public Version Number: 8
DI Record Publish Date: September 18, 2014