DEVICE: ScleroSafe (07290013043092)

Device Identifier (DI) Information

ScleroSafe
VAR350
In Commercial Distribution
VAR1350
V.V.T. MED LTD
07290013043092
GS1

1
532112765 *Terms of Use
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.
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Device Characteristics

Labeling does not contain MRI Safety Information
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Yes
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GMDN

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GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
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.
Active false
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FDA Product Code

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Product Code Product Code Name
KRA Catheter, Continuous Flush
FMF Syringe, Piston
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

a3559c36-5c5d-4d89-8f52-e3beb51fa98b
April 15, 2024
1
April 07, 2024
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
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None
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Production Identifier(s) in UDI

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Customer Contact

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No Customer Contact currently defined
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