Catalog Number

-

Brand Name

D-Stat® Dry topical hemostat

Version/Model Number

3000

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

e6eef221-f567-492b-9dd6-9210c3dfc682

Public Version Date

July 29, 2019

Public Version Number

4

DI Record Publish Date

September 15, 2016

Package DI Number

M20630001

Quantity per Package

10

Contains DI Package

M20630000

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box