| Primary Device ID | 00810209420918 |
| NIH Device Record Key | c519f718-b972-4615-a072-e33849e0bf9c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FlowLogic RipTide |
| Version Model Number | FG-016-00010-01 |
| Catalog Number | FLRTDKIT00 |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Store files in a clean, dry, and dust-free place |
| Special Storage Condition, Specify | Between 0 and 0 *Store files in a clean, dry, and dust-free place |
| Special Storage Condition, Specify | Between 0 and 0 *Store files in a clean, dry, and dust-free place |
| Special Storage Condition, Specify | Between 0 and 0 *Store files in a clean, dry, and dust-free place |
| Special Storage Condition, Specify | Between 0 and 0 *Store files in a clean, dry, and dust-free place |
| Special Storage Condition, Specify | Between 0 and 0 *Store files in a clean, dry, and dust-free place |
| Special Storage Condition, Specify | Between 0 and 0 *Store files in a clean, dry, and dust-free place |
| Special Storage Condition, Specify | Between 0 and 0 *Store files in a clean, dry, and dust-free place |
| Special Storage Condition, Specify | Between 0 and 0 *Store files in a clean, dry, and dust-free place |
| Special Storage Condition, Specify | Between 0 and 0 *Store files in a clean, dry, and dust-free place |
| Special Storage Condition, Specify | Between 0 and 0 *Store files in a clean, dry, and dust-free place |
| Special Storage Condition, Specify | Between 0 and 0 *Store files in a clean, dry, and dust-free place |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810209420918 [Primary] |
| EKS | File, Pulp Canal, Endodontic |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00810209420918]
Moist Heat or Steam Sterilization
[00810209420918]
Moist Heat or Steam Sterilization
[00810209420918]
Moist Heat or Steam Sterilization
[00810209420918]
Moist Heat or Steam Sterilization
[00810209420918]
Moist Heat or Steam Sterilization
[00810209420918]
Moist Heat or Steam Sterilization
[00810209420918]
Moist Heat or Steam Sterilization
[00810209420918]
Moist Heat or Steam Sterilization
[00810209420918]
Moist Heat or Steam Sterilization
[00810209420918]
Moist Heat or Steam Sterilization
[00810209420918]
Moist Heat or Steam Sterilization
[00810209420918]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-01-05 |
| Device Publish Date | 2025-12-26 |
| 00810209420031 - FlowLogic Assert | 2026-01-05 FlowLogic Assert Shaping File 10/.06, 21mm |
| 00810209420451 - FlowLogic Assert | 2026-01-05 FlowLogic Assert Shaping File 10/.04, 31mm |
| 00810209420468 - FlowLogic Assert | 2026-01-05 FlowLogic Assert Shaping File 10/.06, 25mm |
| 00810209420475 - FlowLogic Assert | 2026-01-05 FlowLogic Assert Shaping File 10/.06, 31mm |
| 00810209420536 - FlowLogic Assert | 2026-01-05 FlowLogic Assert Shaping File 15/.04, 31mm |
| 00810209420543 - FlowLogic Assert | 2026-01-05 FlowLogic Assert Shaping File 15/.06, 21mm |
| 00810209420550 - FlowLogic Assert | 2026-01-05 FlowLogic Assert Shaping File 15/.06, 25mm |
| 00810209420567 - FlowLogic Assert | 2026-01-05 FlowLogic Assert Shaping File 15/.06, 31mm |