Catalog Number

-

Brand Name

SURGIFLO® Hemostatic Matrix Kit with Thrombin

Version/Model Number

2994

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

P990004,P990004,P990004,P990004,P990004,P990004,P990004,P990004,P990004,P990004,P990004,P990004,P990004,P990004,P990004,P990004,P990004,P990004,P990004,P990004,P990004,P990004,P990004,P990004,P990004,P990004,P990004,P990004,P990004,P990004,P990004,P990004,P990004,P990004,P990004,P990004,P990004,P990004,P990004,P990004,P990004,P990004,P990004,P990004,P990004,P990004,P990004,P990004,P990004,P990004,P990004,P990004,P990004,P990004

Product Code

LMF

Product Code Name

Agent, Absorbable Hemostatic, Collagen Based

Public Device Record Key

32dca4fd-8ce7-466e-b9c1-0492bd28317e

Public Version Date

September 20, 2022

Public Version Number

13

DI Record Publish Date

May 10, 2016

Package DI Number

25712123000285

Quantity per Package

6

Contains DI Package

15712123000288

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box