Catalog Number

12-194

Brand Name

CROWN SURGICAL

Version/Model Number

HEMOSTATS

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

HRQ

Product Code Name

Hemostat

Public Device Record Key

b4ba4687-7958-423c-bf6a-6148d5963aed

Public Version Date

March 08, 2021

Public Version Number

1

DI Record Publish Date

February 28, 2021

Package DI Number

B924121942

Quantity per Package

400

Contains DI Package

B924121940

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CARDBOARD BOX