Catalog Number

0585-9-211

Brand Name

INSTRUMENT

Version/Model Number

0585-9-211

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

-

Product Code

JDG

Product Code Name

Prosthesis, hip, femoral component, cemented, metal

Public Device Record Key

c7555d17-f0c4-4d9c-bb3e-793cd848f42f

Public Version Date

August 26, 2021

Public Version Number

5

DI Record Publish Date

May 03, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-