Catalog Number

02-04-0610

Brand Name

B-P TOTAL SHOULDER SYSTEM

Version/Model Number

02-04-0610

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

K982418

Product Code

HSD

Product Code Name

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Public Device Record Key

00d243ec-e1b6-471d-834b-64ea0d31ad12

Public Version Date

September 09, 2020

Public Version Number

4

DI Record Publish Date

September 17, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-