| Primary Device ID | 00858395006202 |
| NIH Device Record Key | 48d6293b-e898-4dd8-8759-b9632bc6c272 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | APM Matrix |
| Version Model Number | FG-003-00007 |
| Catalog Number | GW-APM-OMTX |
| Company DUNS | 828894373 |
| Company Name | SONENDO, INC. |
| Device Count | 20 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | false |
| Expiration Date | true |
| 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 |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00858395006202 [Primary] |
| GS1 | 00858395006219 [Unit of Use] |
| ELC | Scaler, Ultrasonic |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-23 |
| 00858395006455 | The APM Matrix is used to form a flat surface on the occlusal surface of a tooth by spreading a |
| 00858395006202 | The APM Matrix is used to form a flat surface on the occlusal surface of a tooth by spreading a |