Identity
- Trade Name
- RocaFlow Irrigation warming System FDA UDI
- Generic Name
- Surgical irrigation/aspiration system FDA UDI
- Device Name
- ENDOFLOW II - Single Chamber Olympus FDA UDI
- Model / Reference
- MEN01US-245 FDA UDI
- Description
- ENDOFLOW II - Single Chamber Olympus FDA UDI
Identifiers
- Catalog Number
- MEN01 FDA UDI
- Primary DI / UDI-DI
- 03700512955184 FDA UDI
- FDA Product Code
- OCX FDA UDI
- GMDN Term
- Surgical irrigation/aspiration system 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
Yes
FDA UDI
Category: Surgical irrigation/aspiration system
RocaFlow Irrigation warming System by Promepla — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical irrigation/aspiration system.
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
- ZOOM Aspiration Pump — Taiwan Biomaterial Co., Ltd. · Class II
- Penumbra System — PENUMBRA, INC. · Class II
- Penumbra System — PENUMBRA, INC. · Class II
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
- Apollo System — PENUMBRA, INC. · Class II
- Apollo System — PENUMBRA, INC. · Class II
- Apollo System — PENUMBRA, INC. · 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 9840e2e5-087b-4e0c-a93d-fa9745c946a6 34 fields · synced May 31, 2026