GEL-FLOW™ NT - Absorbable Hemostatic Sponge, Collagen Based - PHARMACIA & UPJOHN COMPANY LLC

Duns Number:618054084

Device Description: Absorbable Hemostatic Sponge, Collagen Based

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

GEL-FLOW™ NT

Version/Model Number

Hemostatic Matrix for Flowable Applications - 6 mL

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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)

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,N18286,N18286

Product Code Details

Product Code

LMF

Product Code Name

Agent, absorbable hemostatic, collagen based

Device Record Status

Public Device Record Key

36f2b5f7-f981-4e57-aaa1-3ae2b5af97b2

Public Version Date

June 17, 2022

Public Version Number

6

DI Record Publish Date

April 17, 2018

Additional Identifiers

Package DI Number

00300091040061

Quantity per Package

6

Contains DI Package

00300091040016

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