Catalog Number

G000-0100

Brand Name

HemiCAPGRS®

Version/Model Number

G000-0100

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K091196

Product Code

KWS

Product Code Name

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

Public Device Record Key

f97bfae8-cb50-42e8-b869-87569c13e86f

Public Version Date

December 23, 2019

Public Version Number

4

DI Record Publish Date

December 29, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-