Catalog Number

-

Brand Name

PROSTHESIS SHEA TEF CUP S

Version/Model Number

902085

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 01, 2017

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

K760433

Product Code

ETA

Product Code Name

REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL

Public Device Record Key

ce66ef89-ea5b-4420-a6cd-575f1d13b47e

Public Version Date

October 06, 2022

Public Version Number

4

DI Record Publish Date

October 04, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-