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Nitrex™

FDA UDI

Class II (US FDA UDI)

by Ev3, Inc

Identity

Trade Name
NITREX™ FDA UDI
Generic Name
Peripheral vascular guidewire, manual FDA UDI
Device Name
GW N251801 NITREX V04 FDA UDI
Model / Reference
N251801 FDA UDI
Description
GW N251801 NITREX V04 FDA UDI

Identifiers

Primary DI / UDI-DI
00763000185466 FDA UDI
510(k) Number
K040345 FDA UDI
FDA Product Code
DQX FDA UDI
GMDN Term
Peripheral vascular guidewire, manual FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1330 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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Guidewire Diameter — 0.64 Millimeter FDA UDI
Guidewire Length — 180.0 Centimeter FDA UDI

Category: Peripheral vascular guidewire, manual

Nitrex™ by Ev3, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Peripheral vascular guidewire, manual.

Cleared under the same submission

K040345 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ev3, Inc

Sources (1)

  • FDA UDI 0d6d2daa-19cf-498d-afc9-9d29001794dc 37 fields · synced May 30, 2026