FLOSEAL Hemostatic Matrix, 10mL

FLOSEAL Hemostatic Matrix, 10mL
FLOSEAL HEMOSTATIC MATRIX - ADS201845

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: 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: 50085412639609

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00085412639604

Package Quantity: 6

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: CASE

Device Id: 00085412639604

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