Single Use Urinary Guidewire

FDA UDI

Class II (US FDA UDI)

by Zhejiang Chuangxiang Medical Technology Co., LTD.

Identity

Trade Name: Single Use Urinary Guidewire FDA UDI
Generic Name: Gastro-urological guidewire, single-use FDA UDI
Model / Reference: MD-C-UW3820 FDA UDI

Identifiers

Primary DI / UDI-DI: 06936534324814 FDA UDI
FDA Product Code: OCY FDA UDI
GMDN Term: Gastro-urological 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

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Gastro-urological guidewire, single-use

The Single Use Urinary Guidewire is a single-use medical device designed for the insertion and positioning of diagnostic and therapeutic devices within the urinary tract. It features a metal coil or wire coated with plastic material, which can be easily identified by radiopaque graduated markings at its distal end. This device is intended for use in gastroenterology and urology procedures, and is typically used for treatments such as kidney stone removal.

Similar devices

Also classified as Gastro-urological guidewire, single-use.

ZKSK — Beijing ZKSK Technology Co., Ltd · Class II
aneopiston — Yangzhou Fartley Medical Instrument Technology Co., Ltd. · Class I
Tracer Metro — COOK INCORPORATED · Class II
Sterile Hydro-Slide Guidewire — Micro-Tech (Nanjing) Co., Ltd. · Class II
Führungsdraht, "Grip-Wire", Nitinol — MTW - Endoskopie W. Haag KG · Class IIa
Disposable Endoscopy Adapter Set — Yangzhou Fartley Medical Instrument Technology Co., Ltd. · Class I
Valve Kit for PENTAX — Yangzhou Fartley Medical Instrument Technology Co., Ltd. · Class I
Optimos™ Guidewire — Taewoong Medical · 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

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

Manufacturer

Manufacturer: Zhejiang Chuangxiang Medical Technology Co., LTD.

Sources (1)

FDA UDI 8b7d3410-e0fd-4e09-b1b0-66c3235a8cfb 32 fields · synced Oct 6, 2026