ANGIO-SEAL VIP Vascular Closure Device

ANGIO
ANGIO-SEAL - 610131

An implantable, bioabsorbable device designed for haemostasis/closure of a puncture site, through pressure/compression, on a patient having undergone femoral artery catheterization; it is intended as an alternative to manual compression or surgical techniques to reduce the time to haemostasis. It consists of an animal-derived collagen plug that is implanted using an included delivery device (e.g., guidewire, hand-held delivery unit) onto the extravascular surface of the femoral artery access site (top of arteriotomy site), and may be held in place with an included synthetic, bioabsorbable patch/anchor/suture to achieve haemostasis.

• Catheter Gauge: 8 French

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: MGB

Device Name: Device, Hemostasis, Vascular

Device Class: 3

Physical State: N/A

Definition: N/A

Submission Type ID: 2

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Device Id: 50389701011818

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 30389701011814

Package Quantity: 2

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Carton

Device Id: 30389701011814

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00389701011813

Package Quantity: 5

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Shelfbox

Device Id: 00389701011813

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