Identity
- Trade Name
- Hydratome™ EUDAMEDHydratome™ Pro RX 44 FDA UDI
- Generic Name
- ERCP catheter, non-balloon, electrosurgical FDA UDI
- Device Name
- Sphincterotome EUDAMEDFDA UDI
- Model / Reference
- M00584430 EUDAMEDFDA UDI
- Description
- Sphincterotome FDA UDI
Identifiers
- Catalog Number
- M00584430 FDA UDI
- Primary DI / UDI-DI
- 00191506039271 EUDAMEDFDA UDI
- Basic UDI-DI
- 01915060000000000000521MZ EUDAMED
- FDA Product Code
- KNS FDA UDI
- EMDN Code
- G03040202 PAPILLOTOMES / SPHINCTEROTOMES, TRIPLE (OR MORE) LUMEN EUDAMED
- GMDN Term
- ERCP catheter, non-balloon, electrosurgical FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 876.4300 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Category: ERCP catheter, non-balloon, electrosurgical
Hydratome™ Pro RX 44 by Boston Scientific — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as ERCP catheter, non-balloon, electrosurgical.
- Dreamtome™ RX 49 — Boston Scientific · Class II
- Dreamtome™ Pro RX 44 — Boston Scientific · Class II
- Hydratome RX 49 — Boston Scientific · Class II
- Jagtome RX 49 — Boston Scientific · Class II
- Ultratome™ — Boston Scientific · Class II
- Ultratome™ — Boston Scientific · Class II
- Autotome™ RX 39 — Boston Scientific · Class II
- Jagtome RX 49 — Boston Scientific · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Boston Scientific
Sources (2)
- FDA UDI 900fb5b2-4056-492a-a5d2-6ad58ae4ef47 35 fields · synced Jun 18, 2026
- EUDAMED 7d7e428a-f357-4e9d-bfc5-85f0ccf2c92a 61 fields · synced Jun 4, 2026