Identity
- Trade Name
- Roadrunner FDA UDI
- Generic Name
- Gastro-urological guidewire, single-use FDA UDI
- Device Name
- Roadrunner Biliary Wire Guide FDA UDI
- Model / Reference
- G58996 FDA UDI
- Description
- Roadrunner Biliary Wire Guide FDA UDI
Identifiers
- Catalog Number
- RFSPC-35-145-CDES FDA UDI
- Primary DI / UDI-DI
- 00827002589964 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Gastro-urological guidewire, single-use
Roadrunner by Cook Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Gastro-urological guidewire, single-use.
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- Führungsdraht, "Grip-Wire", Nitinol — MTW - Endoskopie W. Haag KG · Class IIa
- Disposable Endoscopy Adapter Set — Yangzhou Fartley Medical Instrument Technology Co., Ltd. · Class I
- Optimos™ Guidewire — Taewoong Medical · Class II
- Single Use Endoscope Valves set — Anrei Medical (HZ) CO., LTD. · Class I
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 Incorporated
Sources (1)
- FDA UDI 480364ad-bd47-41e5-8698-03903b6dc5d6 36 fields · synced Jun 8, 2026