Catalog Number

-

Brand Name

Zimmer

Version/Model Number

ZS-0046

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 09, 2020

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FDG

Product Code Name

Retractor, Fiberoptic

Public Device Record Key

c390dad9-8ad4-4753-a18e-88b7ef8d7293

Public Version Date

January 09, 2020

Public Version Number

4

DI Record Publish Date

December 25, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-