AccessGUDID - DEVICE: ACTEON (03609820877044)

GUDID

Device Identifier (DI) Information

Brand Name: ACTEON
Version or Model: 03.000.405S
Commercial Distribution Status: In Commercial Distribution
Catalog Number: F87704
Company Name: SATELEC

Primary DI Number: 03609820877044
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 381582196 *Terms of Use

Device Description: Circular scalpel angled at 130°, for osteoplasty, harvesting of bone particles or chips. Ridge osteoplasty, periodontal surgery, cysts exerisis, Alternative DI : 10887587009728

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:	Yes
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?
45981	Hard/soft-tissue ultrasonic surgical system	An assembly of devices designed to use ultrasonic energy to mechanically fragment and cut bone and soft tissue, and possibly bone cement 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.	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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8f459b40-e9a6-43f6-807d-41e64ff621ec
Public Version Date: January 21, 2025
Public Version Number: 3
DI Record Publish Date: December 23, 2019