← Back to catalogue

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
M0066201020 FDA UDI

Identifiers

Catalog Number
620-102 FDA UDI
Primary DI / UDI-DI
08714729005735 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
Height — 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

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

Manufacturer

Manufacturer
Lake Region Medical

Sources (1)

  • FDA UDI 77226ad1-41e2-4b47-a854-c6970335e6fc 35 fields · synced Jun 9, 2026