← Back to catalogue

ScleroSafe

FDA UDI

Class II (US FDA UDI)

by V.v.t. Med Ltd

Identity

Trade Name
ScleroSafe FDA UDI
Generic Name
Sclerotherapy dual injection/aspiration catheter FDA UDI
Device Name
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. FDA UDI
Model / Reference
VAR350 FDA UDI
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. FDA UDI

Identifiers

Catalog Number
VAR1350 FDA UDI
Primary DI / UDI-DI
07290013043092 FDA UDI
FDA Product Code
KRA FDA UDI
FMF FDA UDI
GMDN Term
Sclerotherapy dual injection/aspiration catheter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1210 FDA UDI
880.5860 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Sclerotherapy dual injection/aspiration catheter

ScleroSafe by V.v.t. Med Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Sclerotherapy dual injection/aspiration catheter.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
V.v.t. Med Ltd

Sources (1)

  • FDA UDI a3559c36-5c5d-4d89-8f52-e3beb51fa98b 34 fields · synced Jun 6, 2026