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PTFE Coated Urological Guidewire

FDA UDI

Class I (US FDA UDI)

by Lake Region Medical

Identity

Trade Name
PTFE Coated Urological Guidewire FDA UDI
Generic Name
General-purpose non-vascular guidewire FDA UDI
Model / Reference
M0066201000 FDA UDI

Identifiers

Catalog Number
620-100 FDA UDI
Primary DI / UDI-DI
08714729011408 FDA UDI
FDA Product Code
EZB FDA UDI
GMDN Term
General-purpose non-vascular guidewire FDA UDI

Classification

Device Class
Class I 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

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 0.038 Inch FDA UDI
Length — 150 Centimeter FDA UDI

Category: General-purpose non-vascular guidewire

PTFE Coated Urological Guidewire by Lake Region Medical — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General-purpose non-vascular guidewire.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Lake Region Medical

Sources (1)

  • FDA UDI 2593920f-7663-4eac-8af3-7136f6815137 35 fields · synced Jun 9, 2026