Identity
- Trade Name
- RX Cholangiogram Kit FDA UDI
- Generic Name
- General-purpose non-vascular guidewire FDA UDI
- Device Name
- RX Cholangiogram Kit with Pentax Compatible Biopsy Cap FDA UDI
- Model / Reference
- M00575760 FDA UDI
- Description
- RX Cholangiogram Kit with Pentax Compatible Biopsy Cap FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08714729750550 FDA UDI
- FDA Product Code
- NWT FDA UDI
- GMDN Term
- General-purpose non-vascular guidewire 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
Yes
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
No
FDA UDI
Category: Endoscopic electrosurgical electrode, monopolar, single-useGeneral-purpose non-vascular guidewire
RX Cholangiogram Kit by Boston Scientific — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- GLIDEWIRE — Terumo Corp. · Class II
- GLIDEWIRE — Terumo Corp. · Class II
- PTFE Coated Urological Guidewire — Lake Region Medical · 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
- Boston Scientific
Sources (1)
- FDA UDI 2a48f8ea-4737-429f-87cb-d531cf8b2ec0 34 fields · synced Jun 8, 2026