Sterile Hydro-Slide Guidewire

FDA UDI

Class II (US FDA UDI)

by Micro-Tech (Nanjing) Co., Ltd.

Identity

Trade Name: Sterile Hydro-Slide Guidewire FDA UDI
Generic Name: Gastro-urological guidewire, single-use FDA UDI
Device Name: The maximum diameter is 0.035inch,working length is 2600mm,color is yellow & blue,Straight tip,Normal shaft,Smooth surface FDA UDI
Model / Reference: MTN-BM-89/26-A FDA UDI
Description: The maximum diameter is 0.035inch,working length is 2600mm,color is yellow & blue,Straight tip,Normal shaft,Smooth surface FDA UDI

Identifiers

Primary DI / UDI-DI: 06932503510059 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

Dimensions & Sizes

Size: Guidewire Diameter — 0.035 Inch FDA UDI
Guidewire Length — 260 Centimeter FDA UDI

Category: Gastro-urological guidewire, single-use

Sterile Hydro-Slide Guidewire by Micro-Tech (Nanjing) Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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

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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: Micro-Tech (Nanjing) Co., Ltd.

Sources (1)

FDA UDI 33986671-a08b-4ff4-ae4a-ad7bb38257ad 35 fields · synced May 31, 2026