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.

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.
Floseal Hemostatic Matrix - 1503351

A bioabsorbable device derived from animal collagen (e.g., bovine or porcine collagen) designed to produce a rapid haemostasis through platelet activation/aggregation (which initiates the haemostatic cascade leading to a fibrin clot) during a surgical procedure. It is applied directly to the wound where it remains to be absorbed by the body; it is not dedicated to a specific anatomy/application and does not contain an antimicrobial agent. It may be supplied as a fibrillar or soft, pliable pad/sponge or loose fibres; it may be applied in combination with fibrin adhesives. This is a single-use device.

• Total Volume: 10 Milliliter

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: LMF

Device Name: Agent, Absorbable Hemostatic, Collagen Based

Device Class: 3

Physical State: N/A

Definition: N/A

Submission Type ID: 2

Review Panel: SU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: N/A

Regulation Number: 878.4490

Third Party Flag: N

Medical Specialty: SU

Code: PMX

Device Name: Absorbable Collagen Hemostatic Agent With Thrombin

Device Class: 3

Physical State: collagen plus thrombin

Definition: Intended for use as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.

Submission Type ID: 2

Review Panel: SU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Hemostatic agent combining tamponade and acceleration of fibrin clot formation

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: Surgical procedures other than ophthalmic

Regulation Number: 878.4490

Third Party Flag: N

Medical Specialty: SU

Device Id: 00085412096117

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A