ACTEON

Basic Information

• Brand Name: ACTEON
• Primary DI: 03609820599366
• Version / Model: 03.000.400.01S
• Catalog Number: F59936
• Company Name: SATELEC
• Labeler DUNS: 381582196
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-01-17
• Public Version: 1
• Public Version Date: 2025-01-27
• Public Version Status: New
• Public Device Record Key: 4e5899a2-401d-4245-b7bb-3639a7c70efc

Device Description

Irrigation set for ultrasonic surgical system. Alternative DI : 10887587009650

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JDX	Instrument, Surgical, Sonic And Accessory/Attachment	Orthopedic	888.4580	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46102	Surgical irrigation tubing set, single-use	A collection of flexible, noninvasive, single-lumen tubing and associated items intended to provide a conduit to deliver a sterile irrigation solution (e.g., saline) from its source (e.g., gravity feed bag, feed pump) to a surgical cannula (not included) during a surgical procedure (endoscopy, laparoscopy); it is not intended to navigate through an anatomical lumen. The tubing set includes devices such as clamps, filters, spikes, and Y-piece connectors, and may in addition include an integrated manual pump (e.g., a squeeze bulb) or handpiece. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03609820599366	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K100410	000

Storage Conditions

• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 50 – 106 KiloPascal
• Type: Handling Environment Humidity
• Temperature Range: 10 – 70 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 0 – 50 Degrees Celsius