Identity
- Trade Name
- ACTEON FDA UDI
- Generic Name
- Surgical irrigation tubing set, single-use FDA UDI
- Device Name
- Universal sterile irrigation line enables the use of disinfectant solutions (chlorhexidine, sodium hypochlorite), or a saline solution for surgery. FDA UDI
- Model / Reference
- Universal sterile irrigation line FDA UDI
- Description
- Universal sterile irrigation line enables the use of disinfectant solutions (chlorhexidine, sodium hypochlorite), or a saline solution for surgery. FDA UDI
Identifiers
- Catalog Number
- F57370 FDA UDI
- Primary DI / UDI-DI
- 03609820573700 FDA UDI
- 510(k) Number
- K072030 FDA UDI
- FDA Product Code
- EIA FDA UDI
- GMDN Term
- Surgical irrigation tubing set, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6640 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Surgical irrigation tubing set, single-use
Acteon by Satelec — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical irrigation tubing set, single-use.
- SuperFlow Tubing Set — ARMM INC. · Class II
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- EndoGator Hybrid — MEDIVATORS INC. · Class II
- IPC™ Visao® — MEDTRONIC XOMED, INC. · Class II
- Arthrex® — Arthrex, Inc. · Class I
- CODMAN® — Integra LifeSciences Switzerland Sàrl · Class II
- MIDAS REX MR8 — Medtronic Powered Surgical Solutions · Class II
- Endo-Flo — Davol Inc. · Class II
Cleared under the same submission
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 I | Pending data |
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Manufacturer
- Manufacturer
- Satelec
Sources (1)
- FDA UDI 53acdf00-3f44-4084-af63-9298de4edcfd 36 fields · synced Jun 6, 2026