ACTEON F87983

GUDID 03609820879833

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.

SATELEC

Hard/soft-tissue ultrasonic surgical system

• Primary Device ID: 03609820879833
• NIH Device Record Key: b4b1fb06-143c-4b0b-92cf-423327583d79
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACTEON
• Version Model Number: TIP BS2L M+ STERILE
• Catalog Number: F87983
• Company DUNS: 381582196
• Company Name: SATELEC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +3556340607
• Email: info@acteongroup.com
• Phone: +3556340607
• Email: info@acteongroup.com
• Phone: +3556340607
• Email: info@acteongroup.com
• Phone: +3556340607
• Email: info@acteongroup.com
• Phone: +3556340607
• Email: info@acteongroup.com
• Phone: +3556340607
• Email: info@acteongroup.com
• Phone: +3556340607
• Email: info@acteongroup.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	03609820879833 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163610

FDA Product Code

• JDX: Instrument, Surgical, Sonic And Accessory/Attachment

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-04-16
• Device Publish Date: 2019-12-23

On-Brand Devices [ACTEON]

• 03609820573762: Universal sterile irrigation lines (x5) enables the use of disinfectant solutions (chlorhexidine
• 03609820573748: Universal sterile irrigation line enables the use of disinfectant solutions (chlorhexidine, sodi
• 03609820573700: Universal sterile irrigation line enables the use of disinfectant solutions (chlorhexidine, sodi
• 03609820052519: The MINILED is a curing light using second generation L.E.D technology. It's one of the only li
• 03609820052502: The MINILED is a curing light using second generation L.E.D technology. It's one of the only li
• 03609820052229: The MINILED is a curing light using second generation L.E.D technology. It's one of the only li
• 03609820052212: The MINILED is a curing light using second generation L.E.D technology. It's one of the only li
• 03609820876887: Surgical-Osteoplasty
• 03609820876870: Surgical-Osteoplasty
• 03609820876863: Surgical-Osteoplasty
• 03609820876832: Surgical-Osteotomy
• 03609820876825: Surgical-Osteotomy
• 03609820876795: Surgical-Osteotomy
• 03609820876788: Surgical-Osteotomy
• 03609820876771: Surgical-Osteotomy
• 03609820876894: Surgical-Osteoplasty
• 03609820876818: Surgical-Osteoplasty
• 03609820876801: Surgical-Osteotomy
• 03609820876535: Surgical-Osteoplasty
• 03609820876528: Surgical-Osteoplasty
• 03609820876511: Surgical-Osteoplasty
• 03609820876450: Surgical-Membrane detachment
• 03609820876443: Surgical-Osteotomy
• 03609820876436: Surgical-Osteotomy
• 03609820876429: Surgical-Osteotomy
• 03609820876412: Surgical-Osteotomy
• 03609820876344: Surgical-Expansion
• 03609820876337: Surgical-Expansion
• 03609820876320: Surgical-Expansion
• 03609820876313: Surgical-Osteotomy
• 03609820876306: Surgical-Osteotomy
• 03609820876290: Surgical-Osteotomy
• 03609820876283: Surgical-Osteotomy
• 03609820876276: Surgical-Syndesmotomy
• 03609820876269: Surgical-Syndesmotomy
• 03609820876252: Surgical-Syndesmotomy
• 03609820876238: Surgical-Syndesmotomy
• 03609820876221: Surgical-Membrane detachment
• 03609820876214: Surgical-Membrane detachment
• 03609820876207: Surgical-Membrane detachment
• 03609820876191: Surgical-Osteotomy
• 03609820876184: Surgical-Osteotomy
• 03609820876177: Surgical-Osteoplasty
• 03609820876160: Surgical-Osteotomy
• 03609820876153: Surgical-Osteotomy
• 03609820876146: Surgical-Osteotomy
• 03609820876139: Surgical-Osteotomy
• 03609820876122: Surgical-Osteotomy
• 03609820876115: Surgical-Osteotomy
• 03609820876108: Surgical-Osteotomy