Catalog Number

71249852

Brand Name

COFIELD

Version/Model Number

71249852

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 18, 2020

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

-

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

K121714

Product Code

HSD

Product Code Name

PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Public Device Record Key

8a03084f-cd1c-4308-b99d-29d34a1761e4

Public Version Date

October 11, 2021

Public Version Number

5

DI Record Publish Date

August 29, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-