Catalog Number

71335946

Brand Name

R3

Version/Model Number

71335946

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

K113848

Product Code

JDI

Product Code Name

Prosthesis, hip, semi-constrained, metal/polymer, cemented

Public Device Record Key

253a7e35-6ceb-40e9-b1fc-b9f74939c7a9

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 30, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-