SclereSafe
- Primary DI
- 07290013043085
- Brand
- SclereSafe
- Company
- V.V.T. MED LTD
- Model
- VAR150
- Catalog number
- VAR1150
- 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 150mm 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
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- true
- Single use
- true
Related Records
Product Codes
| Code | Name |
|---|---|
| KRA | Catheter, Continuous Flush |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| KRA | Catheter, Continuous Flush | Cardiovascular | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 07290013043085 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 07290013043085 | 07290013043085 | 7290013043085 |
GMDN Terms
| Term | Definition |
|---|---|
| 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. |
Sterilization Methods
| Method |
|---|
Regulatory Flags
- DUNS number
- 532112765
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 07290013043092 | ScleroSafe | VAR350 | VAR1350 | 2024-04-07 |
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