← Back to catalogue

Resonance

FDA UDI

Class II (US FDA UDI)

by Cook Ireland, Ltd.

Identity

Trade Name
Resonance FDA UDI
Generic Name
Ureteral stent-placement set FDA UDI
Device Name
Resonance, Stent Introducer FDA UDI
Model / Reference
G34178 FDA UDI
Description
Resonance, Stent Introducer FDA UDI

Identifiers

Catalog Number
STPV-083070-RMS FDA UDI
Primary DI / UDI-DI
10827002341781 FDA UDI
FDA Product Code
FAD FDA UDI
GMDN Term
Ureteral stent-placement set 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

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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

Yes

FDA UDI

Category: Ureteral stent-placement set

Resonance by Cook Ireland, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ureteral stent-placement set.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Cook Ireland, Ltd.

Sources (1)

  • FDA UDI ed95cb56-8970-4109-a042-410f088c5355 36 fields · synced Jun 8, 2026