← Back to catalogue

Floseal Hemostatic Matrix

FDA PMAFDA UDI

Class III (US FDA PMA)

PMA P990009

by Baxter Healthcare Corp

Identity

Trade Name
FLOSEAL MATRIX/FLOSEAL MATRIX HEMOSTATIC SEALANT/PROCEED HEMOSTATIC SEALANT FDA PMA
FLOSEAL HEMOSTATIC MATRIX FDA UDI
Generic Name
Absorbable collagen hemostatic agent with thrombin FDA PMA
Collagen haemostatic agent, non-antimicrobial FDA UDI
Device Name
FLOSEAL Hemostatic Matrix, 5ml FDA UDI
Model / Reference
ADS201844 FDA UDI
Description
FLOSEAL Hemostatic Matrix, 5ml FDA UDI

Identifiers

Catalog Number
ADS201844 FDA UDI
Primary DI / UDI-DI
00085412639598 FDA UDI
PMA Number
P990009 FDA PMAFDA UDI
FDA Product Code
PMX FDA PMAFDA UDI
GMDN Term
Collagen haemostatic agent, non-antimicrobial FDA UDI

Classification

Device Class
Class III FDA PMAFDA UDI
Legislation / Framework
21 CFR Part 878.4490 FDA PMA
Regulation Number
878.4490 FDA PMAFDA UDI
Advisory Committee
General, Plastic Surgery FDA PMA
FDA Decision
APPR Approved FDA PMA
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Total Volume — 5 Milliliter FDA UDI

The Floseal Hemostatic Matrix is an absorbable collagen hemostatic agent with thrombin, classified as a Class III medical device under FDA regulations. It functions as a fibrin sealant designed to promote hemostasis by forming a gel-like barrier at bleeding sites, particularly in surgical procedures where conventional methods like ligature or suturing are ineffective or impractical.

This sterile, single-use device is supplied as a two-component system (collagen matrix and bovine thrombin) and is intended for use in general and plastic surgery. It must be stored refrigerated and is regulated under FDA Premarket Approval (PMA P990009), with specific product codes (PMX) and registration numbers. The device adheres to FDA’s 878.4490 regulation for absorbable collagen hemostatic agents with thrombin, ensuring compliance with hemostatic sealant standards.

Frequently asked questions

What types of surgical procedures is Floseal Hemostatic Matrix approved for use in, and why is it particularly useful in those settings?

Floseal Hemostatic Matrix is authorized for use in surgical procedures *other than neurosurgical, ophthalmic, and urological* as an adjunct to hemostasis when conventional methods like ligature or suturing are ineffective or impractical. It is particularly useful in general and plastic surgery settings where achieving hemostasis in complex or difficult-to-access areas—such as soft tissue, vascular structures, or high-bleed sites—is challenging. The device’s gel-like barrier formation helps seal bleeding sites, reducing the need for additional sutures or clamps.

Is Floseal Hemostatic Matrix reusable, and if not, how should it be stored to maintain its integrity?

Floseal Hemostatic Matrix is a single-use device and must not be reused. To preserve its sterility and effectiveness, it must be stored refrigerated (following manufacturer guidelines) until use. Improper storage, such as exposure to extreme temperatures or prolonged room-temperature conditions, could compromise its absorbable collagen structure and thrombin activity.

What are the key components of Floseal Hemostatic Matrix, and how does the two-component system work together to achieve hemostasis?

Floseal consists of a two-component system: an absorbable collagen matrix and bovine thrombin. When applied to a bleeding site, the collagen matrix absorbs the thrombin, triggering a biochemical reaction that forms a gel-like seal. This gel acts as a physical barrier while promoting fibrin formation, which helps stabilize blood clots and control hemorrhage. The combination ensures both mechanical occlusion and biochemical hemostasis.

Are there different sizes or models of Floseal available, and how would a clinician determine which one to use?

The Floseal Hemostatic Matrix is supplied in multiple FEI (Final Establishment Identification) numbers, indicating variations in packaging or lot sizes, but the core product remains consistent in its composition and mechanism. Clinicians typically select the appropriate package size based on the anticipated bleeding volume and surgical site complexity. The manufacturer’s instructions should guide selection, though no distinct

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Baxter Healthcare Corp

Sources (2)

  • FDA PMA P990009 24 fields · synced Oct 6, 2026
  • FDA UDI 82de87a4-490b-48b8-9efb-a721847edda3 38 fields · synced May 26, 2026