Single-Use Marked Spring Tip Guidewire

FDA UDI

Class II (US FDA UDI)

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

Identity

Trade Name: Single-Use Marked Spring Tip Guidewire FDA UDI
Generic Name: Endoscopic-access dilator, single-use FDA UDI
Device Name: The diameter of the spring tip is 1.8mm, the diameter of the wire guide rod is 0.8mm, and the effective working length is 2100mm. FDA UDI
Model / Reference: DG-18-08-21 FDA UDI
Description: The diameter of the spring tip is 1.8mm, the diameter of the wire guide rod is 0.8mm, and the effective working length is 2100mm. FDA UDI

Identifiers

Primary DI / UDI-DI: 06932503525114 FDA UDI
FDA Product Code: OCY FDA UDI
GMDN Term: Endoscopic-access dilator, 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 — 0.8 Millimeter FDA UDI
Guidewire Length — 2100 Millimeter FDA UDI

Category: Endoscopic-access dilator, single-use

Single-Use Marked Spring Tip Guidewire by Micro-Tech (Nanjing) Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 4678ebcb-9d84-4109-b5a1-5f25d59ffead 35 fields · synced May 30, 2026