Catalog Number

9195

Brand Name

TIBURON

Version/Model Number

9195

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 01, 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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

LRO

Product Code Name

General Surgery Tray

Public Device Record Key

4bb02e5a-e399-45b9-a281-5421af477e8b

Public Version Date

June 17, 2022

Public Version Number

4

DI Record Publish Date

July 09, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-