| Primary Device ID | 00858395006769 |
| NIH Device Record Key | 49ec3041-0415-4b09-99b4-13f2f1e0a5ce |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GentleWave G4 Support Arm |
| Version Model Number | FG-012-00002 |
| Catalog Number | GW-ARM-0001 |
| Company DUNS | 828894373 |
| Company Name | SONENDO, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 8447663636 |
| info@sonendo.com | |
| Phone | 8447663636 |
| info@sonendo.com | |
| Phone | 8447663636 |
| info@sonendo.com | |
| Phone | 8447663636 |
| info@sonendo.com | |
| Phone | 8447663636 |
| info@sonendo.com | |
| Phone | 8447663636 |
| info@sonendo.com | |
| Phone | 8447663636 |
| info@sonendo.com | |
| Phone | 8447663636 |
| info@sonendo.com | |
| Phone | 8447663636 |
| info@sonendo.com | |
| Phone | 8447663636 |
| info@sonendo.com | |
| Phone | 8447663636 |
| info@sonendo.com | |
| Phone | 8447663636 |
| info@sonendo.com | |
| Phone | 8447663636 |
| info@sonendo.com | |
| Phone | 8447663636 |
| info@sonendo.com | |
| Phone | 8447663636 |
| info@sonendo.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00858395006769 [Primary] |
| EIF | Accessories, Retractor, Dental |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-05-04 |
| Device Publish Date | 2023-04-26 |
| 00858395006776 - GentleWave G4 Console | 2023-07-19 GentleWave G4 Console |
| 00858395006769 - GentleWave G4 Support Arm | 2023-05-04 |
| 00858395006769 - GentleWave G4 Support Arm | 2023-05-04 |
| 00858395006783 - Posterior CleanFlow Procedure Instrument with Matrix | 2023-05-04 CleanFlow Device used with the GentleWave System to treat root canals (Posterior teeth). |
| 00195893912278 - Posterior CleanFlow Procedure Instrument with Matrices | 2022-11-02 Posterior CleanFlow Procedure Instrument with Matrices (Singles) |
| 00858395006622 - GentleWave G4 Console | 2022-11-02 |
| 00858395006745 - Posterior Cleanflow Matrices | 2022-11-02 Posterior Cleanflow Matrices (10 Pack) |
| 00858395006707 - Posterior CleanFlow Procedure Instrument with Matrices | 2022-11-02 Posterior CleanFlow Procedure Instrument with Matrices (10-Pack) |
| 00858395006646 - Premolar CrossFire Procedure Instrument with Matrix | 2020-10-28 Premolar CrossFire Procedure Instrument with Matrix, when used with the Sonendo GentleWave Console, is intended to be used on th |