AccessGUDID - DEVICE: ACTEON (03609820577104)

GUDID

Device Identifier (DI) Information

Brand Name: ACTEON
Version or Model: 05.001.400
Commercial Distribution Status: In Commercial Distribution
Catalog Number: F57710
Company Name: SATELEC

Primary DI Number: 03609820577104
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 381582196 *Terms of Use

Device Description: ultrasonic surgical system for cutting bone and bone substitutes Alternative DI : 10887587025735

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
36273	Ultrasonic surgical system generator	An electrically-powered component of an ultrasonic surgical system intended to generate a high frequency electrical current that is converted, typically within a handpiece, into an ultrasonic oscillation to fragment hard and/or soft tissue cells upon contact with a vibrating tip. It is used in a variety of surgical disciplines (e.g., arthroscopy, gynaecology, neurosurgery, dental/craniomaxillofacial reconstructive surgery); it is not dedicated to dental applications. It provides the controls and monitoring functions for the system during the procedure, and typically regulates energy to the system via a foot-switch; integrated suction/aspiration function may be included.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JDX	Instrument, Surgical, Sonic And Accessory/Attachment

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K100410	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Humidity: between 10 and 100 Percent (%) Relative Humidity
Handling Environment Temperature: between 0 and 50 Degrees Celsius
Handling Environment Atmospheric Pressure: between 50 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: adf93797-9319-40b9-bb93-05c686c49c4c
Public Version Date: January 27, 2025
Public Version Number: 1
DI Record Publish Date: January 17, 2025