Catalog Number

E0014761-1

Brand Name

R3

Version/Model Number

E0014761-1

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 17, 2022

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

K110135

Product Code

LPH

Product Code Name

PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Public Device Record Key

f2071a7f-fe86-481e-8a85-464a3ccb4a51

Public Version Date

March 18, 2022

Public Version Number

4

DI Record Publish Date

July 13, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-