RT3 Surgical Hemostat

RT3 Surgical Hemostat
Vitagel - 2113-0205

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: 4.5 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

Device Id: 00808232001280

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