Catalog Number

71322857

Brand Name

NA

Version/Model Number

71322857

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 17, 2022

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

K823726

Product Code

KWY

Product Code Name

Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented

Public Device Record Key

ef255305-621f-44d9-8598-18890c718dc8

Public Version Date

March 18, 2022

Public Version Number

5

DI Record Publish Date

August 30, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-