Catalog Number

-

Brand Name

GLUTH ALTO PARTIAL

Version/Model Number

678

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 01, 2021

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

K061853

Product Code

ETB

Product Code Name

PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT

Public Device Record Key

9a6a911f-5d13-4051-aa83-10329503cb21

Public Version Date

October 04, 2021

Public Version Number

4

DI Record Publish Date

December 10, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-