ScleroSafe

Basic Information

• Brand Name: ScleroSafe
• Primary DI: 07290013043092
• Version / Model: VAR350
• Catalog Number: VAR1350
• Company Name: V.V.T. MED LTD
• Labeler DUNS: 532112765
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-04-07
• Public Version: 1
• Public Version Date: 2024-04-15
• Public Version Status: New
• Public Device Record Key: a3559c36-5c5d-4d89-8f52-e3beb51fa98b

Device Description

ScleroSafe Peripheral Venous Aspiration & Infusion Kit with Dual Procedure Syringe (DPS) is intended for the delivery of Asclera®, an FDA-approved sclerosant, in the treatment of varicosities in superficial veins with a diameter of 2 to 3mm. ScleroSafe is a sterile, single use device. The Catheter is packaged in a tray which includes all the accessories required for percutaneous introduction using the micropuncture technique. The catheter length is 350mm and is a 5F dual lumen with tapered - tip and two sets of Luer nozzles. ScleroSafe consists of the following components: Micro puncture needle, Nitinol guidewire and plastic torque tool, Dual Lumen Catheter, and Dual procedure syringes (DPS)to allow simultaneous withdrawal of blood and administration of fluids.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KRA	Catheter, Continuous Flush	Cardiovascular	870.1210	2
FMF	Syringe, Piston	General Hospital	880.5860	2

GMDN Terms

Code	Name	Definition	Implantable	Status
66270	Sclerotherapy dual injection/aspiration catheter	A flexible dual-lumen tube designed to be percutaneously introduced into an insufficient vein [commonly the greater saphenous vein (GSV)] to inject sclerosing solution and simultaneously aspirate blood, to shrink and close the varicose vein as part of an endovenous chemical ablation procedure. It is intended to be used with a dedicated injection/aspiration syringe which may be provided with the catheter. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290013043092	GS1