ANGIO
ANGIO-SEAL - C610135
Device Description
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.
Environmental Conditions
- Keep dry and Keep away from sunlight, including UV light. Do not use if temperature indicator dot has changed from light gray to dark gray or black.
- 25.00
- 15.00
Device Sizes
- Catheter Gauge: 8 French
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
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 IdentifiersDevice Id: 50389701011771
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 30389701011777
Package Quantity: 2
Package Discontinue Date: 12/31/2022 12:00:00 AM
Package Status: Not in Commercial Distribution
Package Type: Carton
Device Id: 30389701011777
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 00389701011776
Package Quantity: 5
Package Discontinue Date: 12/31/2022 12:00:00 AM
Package Status: Not in Commercial Distribution
Package Type: Shelfbox
Device Id: 00389701011776
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
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