Catalog Number

1365.54.816

Brand Name

SMR Shoulder

Version/Model Number

1365.54.816

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

K220792

Product Code

KWS

Product Code Name

Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Public Device Record Key

31af322c-0301-4576-b0fe-cf4ab60c51d9

Public Version Date

July 11, 2022

Public Version Number

1

DI Record Publish Date

July 02, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-