Identity
- Trade Name
- Resonance FDA UDI
- Generic Name
- Bare-metal ureteral stent FDA UDI
- Device Name
- Resonance, Metallic Ureteral Stent and Introducer FDA UDI
- Model / Reference
- G34109 FDA UDI
- Description
- Resonance, Metallic Ureteral Stent and Introducer FDA UDI
Identifiers
- Catalog Number
- RMS-060022-R FDA UDI
- Primary DI / UDI-DI
- 10827002341095 FDA UDI
- FDA Product Code
- FAD FDA UDI
- GMDN Term
- Bare-metal 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
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
MR Conditional FDA UDI
Category: Bare-metal ureteral stent
Resonance by Cook Ireland, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bare-metal ureteral stent.
- Resonance — Cook Ireland, Ltd. · Class II
- Resonance — Cook Ireland, Ltd. · Class II
- Resonance — Cook Ireland, Ltd. · Class II
- Resonance — Cook Ireland, Ltd. · Class II
- Resonance — Cook Ireland, Ltd. · 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
- Cook Ireland, Ltd.
Sources (1)
- FDA UDI a1489950-b586-4c43-823b-4c9adeea0021 36 fields · synced May 30, 2026