Catalog Number

71291941

Brand Name

EMPERION

Version/Model Number

71291941

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 27, 2018

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

K042127

Product Code

MEH

Product Code Name

Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate

Public Device Record Key

59609c73-c18e-45d4-9fef-9b5141c46a2c

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 29, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-