AccessGUDID - DEVICE: Anterior/Premolar Procedure Instrument (00858395006196)

GUDID

Device Identifier (DI) Information

Brand Name: Anterior/Premolar Procedure Instrument
Version or Model: FG-003-00002
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: GW-APM-TIXX
Company Name: SONENDO, INC.

Primary DI Number: 00858395006196
Issuing Agency: GS1
Commercial Distribution End Date: December 12, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 828894373 *Terms of Use

Device Description: The Anterior/Premolar Procedure Instrument, when used with the GentleWave Console, is intended to be used on the anterior or premolar teeth indicated for root canal therapy. The device is a hand held dental instrument which contains both fluid delivery and fluid recovery pathways within a polymer casing. The exterior shape of the device is designed to fit the curvature of the human hand and allow ease of application to the procedure site.

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?
60930	Dental delivery system instrument unit, electric	A mains electricity (AC-powered) device designed to make available the necessary instruments/equipment and power to deliver dental treatment to a patient. It consists of a platform for the display of a selection of powered dental instruments (e.g., motor handpiece, scaler, suction, air/water spray), sometimes with a control panel for setting various operating parameters; it may be portable or mounted. The device is commonly referred to as a dental unit or dental operative unit and is intended to be operated by a healthcare professional in a medical facility.	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: 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
Storage Environment Temperature: between 10 and 40 Degrees Celsius
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 69.7 and 106 KiloPascal
Storage Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Handling Environment Temperature: between 18 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0891fb26-4231-49df-8779-46fea2a6aafd
Public Version Date: May 17, 2019
Public Version Number: 3
DI Record Publish Date: September 23, 2016