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Ascension® MCP

FDA UDI

Class III (US FDA UDI)

by Ascension Orthopedics, Inc.

Identity

Trade Name
Ascension® MCP FDA UDI
Generic Name
Metacarpophalangeal joint prosthesis, one-piece FDA UDI
Device Name
Metacarpal-Phalangeal Joint Replacement Device FDA UDI
Model / Reference
MCP10050DWW FDA UDI
Description
Metacarpal-Phalangeal Joint Replacement Device FDA UDI

Identifiers

Catalog Number
MCP-100-50D-WW FDA UDI
Primary DI / UDI-DI
10381780000440 FDA UDI
PMA Number
P000057 FDA UDI
FDA Product Code
NEG FDA UDI
GMDN Term
Metacarpophalangeal joint prosthesis, one-piece FDA UDI

Classification

Device Class
Class III FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Metacarpophalangeal joint prosthesis, one-piece

Ascension® MCP by Ascension Orthopedics, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Metacarpophalangeal joint prosthesis, one-piece.

Cleared under the same submission

P000057 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ascension Orthopedics, Inc.

Sources (1)

  • FDA UDI 931a9546-8025-4607-ab15-c93ed95cb65d 38 fields · synced Jun 8, 2026