Catalog Number

-

Brand Name

ThrombiDisc™ topical hemostat

Version/Model Number

4150

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

e4912af1-8004-4993-99e2-8fa1492114c7

Public Version Date

July 29, 2019

Public Version Number

4

DI Record Publish Date

September 15, 2016

Package DI Number

M20641501

Quantity per Package

25

Contains DI Package

M20641500

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box