UroWire® Guidewire with SL-6® Hydrophilic Coating

FDA UDI

Class II (US FDA UDI)

by Applied Medical Resources Corp.

Identity

Trade Name: UroWire® Guidewire with SL-6® Hydrophilic Coating FDA UDI
Generic Name: General-purpose non-vascular guidewire FDA UDI
Device Name: Urological Guidewire FDA UDI
Model / Reference: B8634 FDA UDI
Description: Urological Guidewire FDA UDI

Identifiers

Primary DI / UDI-DI: 00607915113858 FDA UDI
FDA Product Code: KNY FDA UDI
EZB FDA UDI
GMDN Term: General-purpose non-vascular guidewire FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.5130 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

Dimensions & Sizes

Size: Length — 150 Centimeter FDA UDI
Outer Diameter — 0.35 Inch FDA UDI

Category: General-purpose non-vascular guidewire

UroWire® Guidewire with SL-6® Hydrophilic Coating by Applied Medical Resources Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General-purpose non-vascular guidewire.

Jagwire — Boston Scientific · Class II
GUIDE WIRE M — Terumo Corp. · Class II
GLIDEWIRE — Terumo Corp. · Class II
PTFE Coated Urological Guidewire — Lake Region Medical · Class I
RX Cholangiogram Kit — Boston Scientific · Class II
PTFE Coated Urological Guidewire — LAKE REGION MEDICAL LIMITED · Class I
GLIDEWIRE — Terumo Corp. · Class II
GLIDEWIRE — Terumo Corp. · 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

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Manufacturer

Manufacturer: Applied Medical Resources Corp.

Sources (1)

FDA UDI e76a4bb0-6e4b-49cd-aec5-af408e188d28 35 fields · synced May 30, 2026