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RocaFlow - Irrigation, Warming and Suction System - Double Chamber
FDA UDIClass II (US FDA UDI)
by Promepla
Identity
- Trade Name
- RocaFlow - Irrigation, Warming and Suction System - Double Chamber FDA UDI
- Generic Name
- Endoscopic irrigation/aspiration pump FDA UDI
- Device Name
- with Aspiration Pump FDA UDI
- Model / Reference
- 09-0054 FDA UDI
- Description
- with Aspiration Pump FDA UDI
Identifiers
- Catalog Number
- MEN02PUS FDA UDI
- Primary DI / UDI-DI
- 03700512955252 FDA UDI
- FDA Product Code
- OCX FDA UDI
- GMDN Term
- Endoscopic irrigation/aspiration pump 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
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Endoscopic irrigation/aspiration pump
RocaFlow - Irrigation, Warming and Suction System - Double Chamber by Promepla — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic irrigation/aspiration pump.
- Stabilisation disc — SOPRO-COMEG GmbH · Class II
- Suction and irrigation tube — SOPRO-COMEG GmbH · Class II
- Suction and irrigation tube — SOPRO-COMEG GmbH · Class II
- Suction and irrigation tube — SOPRO-COMEG GmbH · Class II
- LAP-Pump — W.O.M. World of Medicine GmbH · Class II
- Stabilisation disc — SOPRO-COMEG GmbH · Class II
- Vacuum Protection Gas Filter, hydrophobic — W.O.M. World of Medicine GmbH · Class II
- Aspiration cannula — SOPRO-COMEG GmbH · 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
- Promepla
Sources (1)
- FDA UDI a9e386fb-7450-4dcc-a0bc-eeb400cd530d 35 fields · synced May 30, 2026