Porges Coloplast

FDA UDI

Class II (US FDA UDI)

by Coloplast A/S

Identity

Trade Name: Porges Coloplast FDA UDI
Generic Name: Gastro-urological guidewire, single-use FDA UDI
Device Name: Seldinger PTFE-coated guidewire/J-Tip/stiff fixed core, length 80 cm FDA UDI
Model / Reference: AE1138 FDA UDI
Description: Seldinger PTFE-coated guidewire/J-Tip/stiff fixed core, length 80 cm FDA UDI

Identifiers

Catalog Number: AE1138 FDA UDI
Primary DI / UDI-DI: 03600040183991 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: Outer Diameter — 0.038 Inch FDA UDI
Length — 80 Centimeter FDA UDI

Category: Gastro-urological guidewire, single-use

Porges Coloplast by Coloplast A/S — 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: Coloplast A/S

Sources (1)

FDA UDI 5eb7d2e1-bb58-4506-9c5f-bc5d12effec6 37 fields · synced Jun 1, 2026