Posterior CleanFlow Procedure Instrument with Matrices

Basic Information

• Brand Name: Posterior CleanFlow Procedure Instrument with Matrices
• Primary DI: 00195893912278
• Version / Model: FG-013-00004
• Catalog Number: GW-PST-PI01
• Company Name: SONENDO, INC.
• Labeler DUNS: 828894373
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-25
• Public Version: 2
• Public Version Date: 2023-07-19
• Public Version Status: Update
• Public Device Record Key: cb980677-6f6a-45e4-83ba-18c1a0ecab30
• Distribution End Date: 2023-04-28

Device Description

Posterior CleanFlow Procedure Instrument with Matrices (Singles)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ELC	Scaler, Ultrasonic	Dental	872.4850	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00195893912278	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 69.7 – 106 KiloPascal
• Type: Handling Environment Humidity
• Temperature Range: 30 – 75 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 18 – 30 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 30 – 75 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 10 – 40 Degrees Celsius