FLOSEAL HEMOSTATIC MATRIX - Floseal Matrix is indicated in surgical - BAXTER HEALTHCARE CORPORATION

Duns Number:628013963

Device Description: Floseal Matrix is indicated in surgical procedures (other than in ophthalmic) as an adjunc Floseal Matrix is indicated in surgical procedures (other than in ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.

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More Product Details

Catalog Number

ADS201883

Brand Name

FLOSEAL HEMOSTATIC MATRIX

Version/Model Number

ADS201883

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

P990009,P990009,P990009,P990009

Product Code Details

Product Code

PMX

Product Code Name

Absorbable collagen hemostatic agent with thrombin

Device Record Status

Public Device Record Key

50bb92ba-a4cf-4166-848d-839427ce9717

Public Version Date

October 11, 2022

Public Version Number

6

DI Record Publish Date

May 31, 2019

Additional Identifiers

Package DI Number

50085412656309

Quantity per Package

6

Contains DI Package

00085412656304

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"BAXTER HEALTHCARE CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 16
2 A medical device with a moderate to high risk that requires special controls. 101
3 A medical device with high risk that requires premarket approval 19