Catalog Number

-

Brand Name

Thrombi-Gel® thrombin/gelatin foam hemostat

Version/Model Number

0908

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 30, 2021

Issuing Agency

In HIBCC

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

FRO

Product Code Name

Dressing, Wound, Drug

Public Device Record Key

7e9505ba-17ef-4eaa-9312-b3639968f89d

Public Version Date

December 30, 2021

Public Version Number

6

DI Record Publish Date

September 15, 2016

Package DI Number

M20609081

Quantity per Package

5

Contains DI Package

M20609080

Package Discontinue Date

December 30, 2021

Package Status

Not in Commercial Distribution

Package Type

Box