Extended Length ViperWire Advance

FDA UDI

Class II (US FDA UDI)

by Cardiovascular Systems, Inc.

Identity

Trade Name: Extended Length ViperWire Advance FDA UDI
Generic Name: Peripheral vascular guidewire, manual FDA UDI
Device Name: ViperWire, Advance, , Flex Tip, Extended Length, Peripheral, 0.014" Dia spring tip, 475cm, 5 Pack FDA UDI
Model / Reference: VPR-GW-ELFLEX14 FDA UDI
Description: ViperWire, Advance, , Flex Tip, Extended Length, Peripheral, 0.014" Dia spring tip, 475cm, 5 Pack FDA UDI

Identifiers

Catalog Number: 7-10041-01 FDA UDI
Primary DI / UDI-DI: 10852528005732 FDA UDI
FDA Product Code: MCW FDA UDI
GMDN Term: Peripheral vascular guidewire, manual FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.4875 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

Sterilization Method

Ethylene Oxide FDA UDI

Category: Peripheral vascular guidewire, manual

Extended Length ViperWire Advance by Cardiovascular Systems, 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: Cardiovascular Systems, Inc.

Sources (1)

FDA UDI d37a187b-b4fd-4d92-98a6-b1a73b90928c 36 fields · synced May 30, 2026