Catalog Number

-

Brand Name

GLUTH ALTO TOTAL

Version/Model Number

648

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 12, 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

ETA

Product Code Name

REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL

Public Device Record Key

28501513-7d1d-4e89-8b0f-31d77e636087

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

-