Vascular Solutions Custom Access Kit

FDA UDI

Class II (US FDA UDI)

by Vascular Solutions, Inc.

Identity

Trade Name: Vascular Solutions Custom Access Kit FDA UDI
Generic Name: Varicose vein lasing procedure kit FDA UDI
Device Name: The Custom Access Kit is intended to introduce up to a 0.038”/0.89mm guidewire or catheter into the vascular system following a needle stick. FDA UDI
Model / Reference: 7717 FDA UDI
Description: The Custom Access Kit is intended to introduce up to a 0.038”/0.89mm guidewire or catheter into the vascular system following a needle stick. FDA UDI

Identifiers

Primary DI / UDI-DI: M20677171 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

Yes

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: Needle Gauge — 21 Gauge FDA UDI
Catheter Gauge — 4 French FDA UDI

Category: Varicose vein lasing procedure kit

Vascular Solutions Custom Access Kit by Vascular Solutions, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Vascular Solutions, Inc.

Sources (1)

FDA UDI e1ccd523-0fc9-4f63-8b1b-519075c6cfb5 35 fields · synced May 30, 2026