← Back to catalogue

MRWire Guidewire

FDA UDI

Class II (US FDA UDI)

by Contract Medical International GmbH

Identity

Trade Name
MRWire Guidewire FDA UDI
Generic Name
Cardiac/peripheral vascular guidewire, single-use FDA UDI
Device Name
The MRWire Guide Wire is a sterile, disposable guide wire for the introduction and/or placement of diagnostic or interventional devices. The MRWire is constructed from a high strength core composite of glass fibers and polymers, protected by a high-strength aramid fiber mantle and covered with a PTFE extrusion. The hydrophobic extrusion reduces intravascular friction in devices such as catheters. The distal tip of the MRWire is marked with discrete ring markers for MRI and X-Ray visibility and comes in different configurations such as straight and angled. Guide wires are supplied sterile and non-pyrogenic. The MRWire’s diameter is 0.035” (0.89 mm). FDA UDI
Model / Reference
Straight MR Wire FDA UDI
Description
The MRWire Guide Wire is a sterile, disposable guide wire for the introduction and/or placement of diagnostic or interventional devices. The MRWire is constructed from a high strength core composite of glass fibers and polymers, protected by a high-strength aramid fiber mantle and covered with a PTFE extrusion. The hydrophobic extrusion reduces intravascular friction in devices such as catheters. The distal tip of the MRWire is marked with discrete ring markers for MRI and X-Ray visibility and comes in different configurations such as straight and angled. Guide wires are supplied sterile and non-pyrogenic. The MRWire’s diameter is 0.035” (0.89 mm). FDA UDI

Identifiers

Catalog Number
CV-G-18035S FDA UDI
Primary DI / UDI-DI
04251244500429 FDA UDI
510(k) Number
K173423 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

Dimensions & Sizes

Size
Outer Diameter — 0.035 Inch FDA UDI
Length — 180 Centimeter FDA UDI

Category: Cardiac/peripheral vascular guidewire, single-use

MRWire Guidewire by Contract Medical International GmbH — 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

K173423 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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

Manufacturer

Manufacturer
Contract Medical International GmbH

Sources (1)

  • FDA UDI 72fdfba9-15cf-4248-91fc-acb6f2383add 38 fields · synced May 30, 2026