Catalog Number

011998

Brand Name

Zimmer Biomet Timberline Lateral Fusion System Wave Guide

Version/Model Number

8735-0042

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

-

Product Code

FDG

Product Code Name

Retractor, Fiberoptic

Public Device Record Key

53c1a12e-bedc-4216-abb8-5ac78e13cf45

Public Version Date

March 01, 2022

Public Version Number

1

DI Record Publish Date

February 21, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-