ACTEON

Basic Information

• Brand Name: ACTEON
• Primary DI: 03609820879734
• Version / Model: TIP SL2 M+ STERILE
• Catalog Number: F87973
• Company Name: SATELEC
• Labeler DUNS: 381582196
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-12-23
• Public Version: 1
• Public Version Date: 2019-12-31
• Public Version Status: New
• Public Device Record Key: 822fd045-2146-4552-be97-805b819af07c

Device Description

Osteotomy, osteoplasty, decorticating, drilling, shaping and smoothing of the bones and teeth in various surgical procedures, including but not limited to general, orthopedic, otolaryngologic, maxillofacial, oral, hand/foot, neurosurgery, spinal, and plastic/reconstructive surgery

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
45981	Hard-tissue ultrasonic surgical system	An assembly of devices designed to use ultrasonic energy to mechanically fragment and cut bone and/or bone cement [e.g., acrylic, polymethylmethacrylate (PMMA)] upon contact during an orthopaedic surgical procedure (e.g., arthroplasty revision, spinal surgery); some types may in addition be intended for dental/craniomaxillofacial applications (e.g., reconstructive/plastic surgery) however none are dedicated exclusively to dental applications. It typically includes an ultrasonic energy-producing generator, a handpiece with cutting tip(s)/probe(s) to apply the energy and remove (aspirate) material, and connecting cables.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03609820879734	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K163610	000