CLOSURE SYSTEM VS
VenaSeal™ - VS-404
Device Description
A collection of sterile devices intended to be used for the endovascular closure of the great saphenous vein (GSV) and associated varicosities as a treatment for varicose veins. It typically includes a surgical adhesive (e.g., cyanoacrylate), syringe, delivery catheter, dilator, introducer and a dispensing gun. The adhesive is typically delivered under ultrasonic control at prescribed intervals throughout the length of the affected vein to adhere the vessel walls together, resulting in the complete and permanent closure of the lumen. This is a single-use device.
Environmental Conditions
- Keep dry. VenaSeal system should be stored in its dispenser box carton at room temperature and humidity.
Device Sizes
No Data Available
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: PJQ
Device Name: Agent, Occluding, Vascular, Permanent
Device Class: 3
Physical State: The device consists of a polymerizing glue and delivery system for injection into the vasculature.
Definition: The device is a polymerizing agent intended for permanent occlusion of peripheral blood vessels.
Submission Type ID: 2
Review Panel: CV
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: The material polymerizes in the vessel to permanently coapt or occlude the vessel.
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: Y
Target Area: Peripheral vasculature
Regulation Number: N/A
Third Party Flag: N
Medical Specialty: N/A
Device IdentifiersDevice Id: 00763000240776
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
Device Id: 20763000240770
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 00763000240776
Package Quantity: 5
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: PK
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