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Traxcess Guidewire

FDA UDI

Class II (US FDA UDI)

by Microvention Inc.

Identity

Trade Name
Traxcess Guidewire FDA UDI
Generic Name
Cardiac/peripheral vascular guidewire, single-use FDA UDI
Device Name
Guidewires FDA UDI
Model / Reference
GW1420040-OUS FDA UDI
Description
Guidewires FDA UDI

Identifiers

Catalog Number
GW1420040 FDA UDI
Primary DI / UDI-DI
00811425021330 FDA UDI
510(k) Number
K080863 FDA UDI
FDA Product Code
DQX FDA UDI
GMDN Term
Cardiac/peripheral vascular guidewire, single-use 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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Cardiac/peripheral vascular guidewire, single-use

Traxcess Guidewire by Microvention Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiac/peripheral vascular guidewire, single-use.

Cleared under the same submission

K080863 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Microvention Inc.

Sources (1)

  • FDA UDI 833489ef-8164-4cdf-b3ec-774f1209a7f5 37 fields · synced Jun 1, 2026