GELFOAM PLUS is an implantable hemostat supplied as a ready to use medical device kit containing GELFOAM® Sterile Sponge, Thrombin Human lyophilized powder, two 10 mL Prefilled Saline Syringes 0.9 Percent Sodium Chloride Injection USP, and a Vial Access Device

GELFOAM PLUS is an implantable hemostat supplied as a ready to use medical device kit containing GELFOAM® Sterile Sponge, Thrombin Human lyophilized powder, two 10 mL Prefilled Saline Syringes 0.9 Percent Sodium Chloride Injection USP, and a Vial Access Device
Gelfoam Plus - 1501341

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.

No Data Available

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: 50085412086304

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00085412086309

Package Quantity: 6

Package Discontinue Date: 10/20/2021 12:00:00 AM

Package Status: Not in Commercial Distribution

Package Type: CASE

Device Id: 00085412086309

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