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Urological Guide Wire

FDA UDI

Class II (US FDA UDI)

by Well Lead Medical Co., Ltd

Identity

Trade Name
Urological Guide Wire FDA UDI
Generic Name
Cardiac/peripheral vascular guidewire, single-use FDA UDI
Device Name
NS-032 FDA UDI
Model / Reference
U01B133215 FDA UDI
Description
NS-032 FDA UDI

Identifiers

Primary DI / UDI-DI
06936881148347 FDA UDI
FDA Product Code
OCY FDA UDI
GMDN Term
Cardiac/peripheral vascular guidewire, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 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

Category: Cardiac/peripheral vascular guidewire, single-use

Urological Guide Wire by Well Lead Medical Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Well Lead Medical Co., Ltd

Sources (1)

  • FDA UDI 899f05e7-c1e3-47a1-a9e0-6508d78f4802 33 fields · synced Jun 8, 2026