Catalog Number

12-188

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

d0ca578f-73f4-404d-9919-68b896f2ec20

Public Version Date

March 15, 2021

Public Version Number

1

DI Record Publish Date

March 05, 2021

Package DI Number

B924121882

Quantity per Package

600

Contains DI Package

B924121880

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CARDBOARD BOX