Catalog Number

01.06010.302

Brand Name

Avenir® Müller

Version/Model Number

01.06010.302

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

KWL

Product Code Name

Prosthesis, hip, hemi-, femoral, metal

Public Device Record Key

ef65aa16-349e-48e3-ae92-2241570a4804

Public Version Date

October 12, 2021

Public Version Number

3

DI Record Publish Date

June 25, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-