Catalog Number

71337059

Brand Name

Contour

Version/Model Number

71337059

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

K962541

Product Code

JDJ

Product Code Name

Mesh, surgical, acetabular, hip, prosthesis

Public Device Record Key

fe91e65a-1e9a-4f1b-9b71-78bd2985a4ad

Public Version Date

June 10, 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

-