Catalog Number

71331860

Brand Name

R3 ACETABULAR

Version/Model Number

71331860

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

-

Product Code

MBL

Product Code Name

Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous

Public Device Record Key

87ce1735-f055-4a50-bf2f-d7d1ed9c48fb

Public Version Date

September 09, 2020

Public Version Number

4

DI Record Publish Date

May 04, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-