Catalog Number

12-183-FP

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

20316e0b-f03b-4084-aa72-d8a7ccc3110d

Public Version Date

February 08, 2021

Public Version Number

1

DI Record Publish Date

January 30, 2021

Package DI Number

B92412183FP2

Quantity per Package

500

Contains DI Package

B92412183FP0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CARDBOARD BOX