Acteon

FDA UDIEUDAMED

Class I (US FDA UDI)

Ref F57374

by Satelec

Identity

Trade Name: ACTEON FDA UDI
Generic Name: Surgical irrigation tubing set, single-use FDA UDI
Device Name: Sterilizable Irrigation Tubing EUDAMED
Universal sterile irrigation line enables the use of disinfectant solutions (chlorhexidine, sodium hypochlorite), or a saline solution for surgery. FDA UDI
Model / Reference: F57374 EUDAMED
Sterile irrigation line + perfo 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: F57374 FDA UDI
Primary DI / UDI-DI: 03609820573748 EUDAMEDFDA UDI
Basic UDI-DI: 360982SAS50Aa062000XC EUDAMED
510(k) Number: K072030 FDA UDI
FDA Product Code: EIA FDA UDI
EMDN Code: A03040299 IRRIGATION KITS, SINGLE-USE - OTHER EUDAMED
GMDN Term: Surgical irrigation tubing set, single-use FDA UDI

Classification

Device Class: Class I EUDAMEDFDA UDI
Regulation Number: 872.6640 FDA UDI
Medical Purpose: Non-sterile Irrigation Line and Spike Procedure Packs EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Surgical irrigation tubing set, single-use

Acteon by Satelec — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Surgical irrigation tubing set, single-use.

SuperFlow Tubing Set — ARMM INC. · Class II
Irrigation Set — B. BRAUN MEDICAL INC. · Class II
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

K072030 also covers:

ACTEON — Satelec
ACTEON — Satelec

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 I	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Satelec

Sources (2)

FDA UDI 5b77e8a9-166e-45d8-ab2f-3d6cf4da98b0 36 fields · synced Jun 19, 2026
EUDAMED e324e804-cb98-4e61-b72b-a48c9eab4f1b 61 fields · synced Jun 19, 2026