Catalog Number

-

Brand Name

SURGIFLO® Hemostatic Matrix Kit with Thrombin

Version/Model Number

2993

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 30, 2017

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"

-

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

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

963cec92-60d4-4dfd-99ae-8216d5262e64

Public Version Date

August 08, 2018

Public Version Number

4

DI Record Publish Date

September 20, 2014

Package DI Number

25712123000322

Quantity per Package

6

Contains DI Package

15712123000325

Package Discontinue Date

November 30, 2017

Package Status

Not in Commercial Distribution

Package Type

Box