ScleroSafe

Primary DI
07290013043092
Brand
ScleroSafe
Company
V.V.T. MED LTD
Model
350
Catalog number
VAR1350
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.
Published
2024-04-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FMFSyringe, Piston
KRACatheter, Continuous Flush

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2
KRACatheter, Continuous FlushCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231148000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231148000ScleroSafe™ 150 mm, ScleroSafe™ 350 mmVvt Medical , Ltd.2023-06-20KRA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290013043092PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290013043092072900130430927290013043092

GMDN Terms#

Term, Definition table
TermDefinition
Sclerotherapy dual injection/aspiration catheterA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
532112765
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290013043085SclereSafe150VAR11502024-04-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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