Catalog Number

521348

Brand Name

NA

Version/Model Number

5213-48

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 04, 2019

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

K072578

Product Code

HSD

Product Code Name

PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Public Device Record Key

9033d4c0-a19b-47e3-95b8-20a7c10e9e2a

Public Version Date

December 23, 2019

Public Version Number

6

DI Record Publish Date

September 14, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-