FDA UDI
In Commercial Distribution
🇺🇸 United States
GentleWave Console
DI: 00858395006226
·
Model: FG-002-00001
·
SONENDO, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- GentleWave Console
- Primary DI
- 00858395006226
- Version / Model
- FG-002-00001
- Company Name
- SONENDO, INC.
- Labeler DUNS
- 828894373
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 6d49acc6-8d7a-463f-a827-d209cf3605d9
Device Description
The GentleWave Console is a semi-stationary unit designed to prepare and deliver a procedure fluid to the Anterior/Premolar or Molar Procedure Instruments. The Procedure Instruments are used to deliver the procedure fluid to the selected anterior or premolar tooth when used with the Anterior/Premolar Procedure Instrument and the selected molar tooth when used with the Molar Procedure Instrument.
Device Characteristics
- Single Use
- No
- 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
- Yes
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- 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 | 00858395006226 | GS1 |
Customer Contacts
- Phone
- 8447663636
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 30 – 75 Percent (%) Relative Humidity
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 69.7 – 106 KiloPascal
- Type
- Handling Environment Temperature
- Temperature Range
- 18 – 30 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 30 – 75 Percent (%) Relative Humidity