ViperWire Advance FlexTip

FDA UDI

Class II (US FDA UDI)

by Cardiovascular Systems, Inc.

Identity

Trade Name: ViperWire Advance FlexTip FDA UDI
Generic Name: Peripheral vascular guidewire, manual FDA UDI
Device Name: VIPERWIRE, ADVANCE FLEXTIP PERIPHERAL, .018" DIA SPRING TIP, 335CM, 5 PACK FDA UDI
Model / Reference: VPR-GW-FT14 FDA UDI
Description: VIPERWIRE, ADVANCE FLEXTIP PERIPHERAL, .018" DIA SPRING TIP, 335CM, 5 PACK FDA UDI

Identifiers

Catalog Number: 7-10026-01 FDA UDI
Primary DI / UDI-DI: 10852528005312 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

Dimensions & Sizes

Size: Length — 335 Centimeter FDA UDI

Category: Peripheral vascular guidewire, manual

ViperWire Advance FlexTip by Cardiovascular Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Peripheral vascular guidewire, manual.

Cook — COOK INCORPORATED · Class II
Cook — COOK INCORPORATED · Class II
Cook — COOK INCORPORATED · Class II
Cook — COOK INCORPORATED · Class II
GO2WIRE™ — Merit Medical Systems, Inc. · Class II
Merit Laureate® — Merit Medical Systems, Inc. · Class II
Cook — COOK INCORPORATED · Class II
Selectiva — HERAEUS MEDICAL COMPONENTS LLC · Class II

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Cardiovascular Systems, Inc.

Sources (1)

FDA UDI 71d80fc9-c8fa-4473-b208-f422ae53bb4b 36 fields · synced Jun 8, 2026