Catalog Number

9365-99-153

Brand Name

NA

Version/Model Number

9365-99-153

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

-

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

K022985

Product Code

JDJ

Product Code Name

Mesh, surgical, acetabular, hip, prosthesis

Public Device Record Key

7cb421e9-bcf1-4110-9503-ba1f19768c90

Public Version Date

July 08, 2021

Public Version Number

7

DI Record Publish Date

July 18, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-