VenaCure EVLT

FDA UDI

Class II (US FDA UDI)

by Angiodynamics, Inc

Identity

Trade Name: VenaCure EVLT FDA UDI
Generic Name: Varicose vein lasing procedure kit FDA UDI
Device Name: NeverTouch FRS 90cm Procedure Kit FDA UDI
Model / Reference: 11403004 FDA UDI
Description: NeverTouch FRS 90cm Procedure Kit FDA UDI

Identifiers

Primary DI / UDI-DI: H787114030040 FDA UDI
510(k) Number: K112600 FDA UDI
K162914 FDA UDI
K171921 FDA UDI
K231945 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

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Length — 90 Centimeter FDA UDI
Needle 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

K112600 also covers:

K162914 also covers:

K171921 also covers:

K231945 also covers:

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 4dd9507b-f30b-42d7-a59d-b07be2fa13be 37 fields · synced Jun 20, 2026