Identity
- Trade Name
- VenaCure EVLT FDA UDI
- Generic Name
- Varicose vein lasing procedure kit FDA UDI
- Device Name
- NeverTouch FRS 65cm Procedure Kit FDA UDI
- Model / Reference
- 51403002 FDA UDI
- Description
- NeverTouch FRS 65cm Procedure Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- H787514030020 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- Varicose vein lasing procedure kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 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
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 65 Centimeter FDA UDINeedle Gauge — 21 Gauge FDA UDI
Category: Varicose vein lasing procedure kit
VenaCure EVLT by Angiodynamics, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K102796 also covers:
K162914 also covers:
- VenaCure EVLT — ANGIODYNAMICS, INC
- VenaCure EVLT — ANGIODYNAMICS, INC
- VenaCure EVLT — ANGIODYNAMICS, INC
- VenaCure EVLT — ANGIODYNAMICS, INC
- VenaCure EVLT — ANGIODYNAMICS, INC
- VenaCure EVLT — ANGIODYNAMICS, INC
- VenaCure EVLT — ANGIODYNAMICS, INC
- VenaCure EVLT — ANGIODYNAMICS, INC
- VenaCure EVLT — ANGIODYNAMICS, INC
- VenaCure EVLT — ANGIODYNAMICS, INC
- VenaCure EVLT — ANGIODYNAMICS, INC
- VenaCure EVLT — ANGIODYNAMICS, INC
K171921 also covers:
- VenaCure EVLT — ANGIODYNAMICS, INC
- VenaCure EVLT — ANGIODYNAMICS, INC
- VenaCure EVLT — ANGIODYNAMICS, INC
- VenaCure EVLT — ANGIODYNAMICS, INC
- VenaCure EVLT — ANGIODYNAMICS, INC
- VenaCure EVLT — ANGIODYNAMICS, INC
- VenaCure EVLT — ANGIODYNAMICS, INC
- VenaCure EVLT — ANGIODYNAMICS, INC
- VenaCure EVLT — ANGIODYNAMICS, INC
- VenaCure EVLT — ANGIODYNAMICS, INC
- VenaCure EVLT — ANGIODYNAMICS, INC
- VenaCure EVLT — ANGIODYNAMICS, INC
K231945 also covers:
- VenaCure EVLT — ANGIODYNAMICS, INC
- VenaCure EVLT — ANGIODYNAMICS, INC
- VenaCure EVLT — ANGIODYNAMICS, INC
- VenaCure EVLT — ANGIODYNAMICS, INC
- VenaCure EVLT — ANGIODYNAMICS, INC
- VenaCure EVLT — ANGIODYNAMICS, INC
- VenaCure EVLT — ANGIODYNAMICS, INC
- VenaCure EVLT — ANGIODYNAMICS, INC
- VenaCure EVLT — ANGIODYNAMICS, INC
- VenaCure EVLT — ANGIODYNAMICS, INC
- VenaCure EVLT — ANGIODYNAMICS, INC
- VenaCure EVLT — ANGIODYNAMICS, INC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Angiodynamics, Inc
Sources (1)
- FDA UDI 25c52a2f-ab82-4bfd-840f-60c25ecd380e 37 fields · synced Jun 20, 2026