Porges Coloplast

FDA UDI

Class II (US FDA UDI)

by Coloplast A/S

Identity

Trade Name: Porges Coloplast FDA UDI
Generic Name: Polymeric ureteral stent FDA UDI
Device Name: VORTEK® Double loop ureteral stent with hydrogel coating open/open CH FR 4.8 length 28 cm with steerable pusher and fixed core guidewire FDA UDI
Model / Reference: BCFA45 FDA UDI
Description: VORTEK® Double loop ureteral stent with hydrogel coating open/open CH FR 4.8 length 28 cm with steerable pusher and fixed core guidewire FDA UDI

Identifiers

Catalog Number: BCFA45 FDA UDI
Primary DI / UDI-DI: 05708932062169 FDA UDI
FDA Product Code: FAD FDA UDI
GMDN Term: Polymeric ureteral stent FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.4620 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Safe FDA UDI

Dimensions & Sizes

Size: Length — 28 Centimeter FDA UDI
Catheter Gauge — 4.8 French FDA UDI

Category: Polymeric ureteral stent

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

Similar devices

Also classified as Polymeric ureteral stent.

Polaris™ Loop — Boston Scientific · Class II
Percuflex™ Plus — Boston Scientific · Class II
Percuflex™ Plus — Boston Scientific · Class II
Polaris™ Ultra — Boston Scientific · Class II
Q UROLOGICAL PERSISTENT AGUAMEDICINA — Q Urological Corporation · Class II
Universa — COOK INCORPORATED · Class II
TECOFLEX — Gyrus Acmi, Inc. · Class II
Universa — Cook, Inc. · 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 8de6ecc6-e826-49cf-9d0f-04ed45188d53 37 fields · synced Jun 8, 2026