Coloplast

FDA UDI

Class II (US FDA UDI)

by Coloplast A/S

Identity

Trade Name: Coloplast FDA UDI
Generic Name: Gastro-urological guidewire, single-use FDA UDI
Model / Reference: AE0E38 FDA UDI

Identifiers

Catalog Number: AE0E38 FDA UDI
Primary DI / UDI-DI: 03600040968093 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

MRI Safety

MR Unsafe FDA UDI

Dimensions & Sizes

Size: Length — 90 Centimeter FDA UDI
Outer Diameter — 0.038 Inch FDA UDI

Category: Gastro-urological guidewire, single-use

Coloplast by Coloplast A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

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Single Use Urinary Guidewire — Zhejiang Chuangxiang Medical Technology 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
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

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Manufacturer

Manufacturer: Coloplast A/S

Sources (1)

FDA UDI 0b3053dd-1efe-4361-a4b8-35a1a0a2bdf8 36 fields · synced Jun 6, 2026