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Vortek

FDA UDI

Class II (US FDA UDI)

by Coloplast A/S

Identity

Trade Name
Vortek FDA UDI
Generic Name
Polymeric ureteral stent FDA UDI
Device Name
Vortek . iso. Single loop ureteral stent. Ø0.035" (0.89mm). PTFE-coated guidewire / stiff. FDA UDI
Model / Reference
ACA106 FDA UDI
Description
Vortek . iso. Single loop ureteral stent. Ø0.035" (0.89mm). PTFE-coated guidewire / stiff. FDA UDI

Identifiers

Catalog Number
ACA106 FDA UDI
Primary DI / UDI-DI
03600040910986 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

Yes

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Polymeric ureteral stent

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

Similar devices

Also classified as Polymeric ureteral stent.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Coloplast A/S

Sources (1)

  • FDA UDI 75500f20-0b80-4ebb-8eaa-3853b0eeb0c8 35 fields · synced Jun 6, 2026