Catalog Number

-

Brand Name

SURGIFOAM® Absorbable Gelatin Sponge, U.S.P. Oral Sponge

Version/Model Number

1969

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"

-

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,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

b1247f66-aac5-4431-9584-54e2ead0ec0c

Public Version Date

September 20, 2022

Public Version Number

11

DI Record Publish Date

September 20, 2014

Package DI Number

25712123000148

Quantity per Package

24

Contains DI Package

15712123000141

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-