AccessGUDID - DEVICE: ACTEON (03609820001159)

GUDID

Device Identifier (DI) Information

Brand Name: ACTEON
Version or Model: TIP H4R
Commercial Distribution Status: In Commercial Distribution
Catalog Number: F00115
Company Name: SATELEC

Primary DI Number: 03609820001159
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 381582196 *Terms of Use

Device Description: Periodontics for the premolar and molar sectors, right-oriented Second instrument in the sequence, it follows the use of the H4L tip. • Maxillary: palatine and mesial surfaces of sector 2, pivots at 13, then buccal and distal surfaces of sector 1. • Mandibular: lingual and mesial surfaces of sector 4, pivots at 43, then buccal and distal surfaces of sector 3.

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?
44908	Ultrasonic dental scaling/debridement system handpiece tip, periodontal	An insert intended to be attached to an ultrasonic dental scaling/debridement system handpiece, to transmit ultrasonic energy (e.g., 25 kHz/30 kHz) from a generator to the oral cavity for the removal of accretions from tooth surfaces during dental cleaning or periodontal therapy; it is not intended for endodontic use. This device vibrates at a high frequency to provide the scaling effect. Water or a rinsing solution (e.g., chlorhexidine) is intended to be fed through the handpiece/tip assembly to assist in the process. This device is available in a variety of designs and tip shapes. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ELC	Scaler, Ultrasonic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: 3f3f7326-7808-427b-a53f-89eae1a4fa9b
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 2016