Catalog Number

MCP-100-30D-WW

Brand Name

Ascension® MCP

Version/Model Number

MCP10030DWW

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

P000057

Product Code

NEG

Product Code Name

Finger Semi-Constrained Pyrolytic Carbon Uncemented Prosthesis

Public Device Record Key

071ecf39-a955-479b-8201-21017bb2332d

Public Version Date

December 29, 2020

Public Version Number

6

DI Record Publish Date

September 18, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-