Identity
- Trade Name
- COMEG MEDICAL FDA UDI
- Generic Name
- Endoscopic irrigation/aspiration pump FDA UDI
- Device Name
- This machine controls the introduction of liquid into an articulation during arthroscopic surgery. It can be used for diagnostic purposes as well as arthroscopic surgery and enables intra-articular distension to be maintained and rinsing to be carried out. FDA UDI
- Model / Reference
- S670 - IRRIGATEUR - SOPRO - US FDA UDI
- Description
- This machine controls the introduction of liquid into an articulation during arthroscopic surgery. It can be used for diagnostic purposes as well as arthroscopic surgery and enables intra-articular distension to be maintained and rinsing to be carried out. FDA UDI
Identifiers
- Catalog Number
- S_670_0002 FDA UDI
- Primary DI / UDI-DI
- M430S67000021 FDA UDI
- 510(k) Number
- K080122 FDA UDI
- FDA Product Code
- HRX FDA UDI
- GMDN Term
- Endoscopic irrigation/aspiration pump FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.1100 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: Endoscopic irrigation/aspiration pump
Comeg Medical by Sopro — 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
- RocaFlow II - Double Chamber with Aspiration Pump — Promepla · 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
- RocaFlow II - Simple Chamber — Promepla · Class II
- LAP-Pump — W.O.M. World of Medicine GmbH · Class II
- Stabilisation disc — 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
- Sopro
Sources (1)
- FDA UDI 294c0014-b435-464c-a9d5-a95ccc47298a 36 fields · synced May 30, 2026