Gelfoam - Absorbable Hemostatic Sponge, Collagen Based - PHARMACIA & UPJOHN COMPANY LLC

Duns Number:618054084

Device Description: Absorbable Hemostatic Sponge, Collagen Based

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More Product Details

Catalog Number

-

Brand Name

Gelfoam

Version/Model Number

Size 12-7

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

N18286,N18286,N18286,N18286,N18286,N18286,N18286,N18286,N18286,N18286,N18286,N18286,N18286,N18286,N18286,N18286

Product Code Details

Product Code

LMF

Product Code Name

Agent, absorbable hemostatic, collagen based

Device Record Status

Public Device Record Key

87463f38-6e9c-40ee-8ad7-f50a5881967c

Public Version Date

December 17, 2020

Public Version Number

6

DI Record Publish Date

September 01, 2014

Additional Identifiers

Package DI Number

00300090315085

Quantity per Package

12

Contains DI Package

10300090315082

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton

"PHARMACIA & UPJOHN COMPANY LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 5
3 A medical device with high risk that requires premarket approval 11