| Primary Device ID | 00817744022720 |
| NIH Device Record Key | a4024e30-046c-4120-b708-df2e67b0e3c9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Primo Freeze |
| Version Model Number | RE100SP |
| Company DUNS | 121411859 |
| Company Name | ECOTEC MANUFACTURING, 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817744022720 [Primary] |
| EAT | Tester, Pulp |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-10-10 |
| Device Publish Date | 2024-10-02 |
| 00817744022720 - Primo Freeze | 2024-10-10Endo Freeze Spray |
| 00817744022720 - Primo Freeze | 2024-10-10 Endo Freeze Spray |
| 00752080000035 - SkyChoice Polar-Freeze | 2024-10-03 Endo Freeze Spray |
| 00752080000028 - Hexa Freeze | 2024-10-02 Endo Freeze Spray |
| 00752080000011 - RMH3 Dental | 2024-08-27 Endo Freeze Spray |
| 00810132807435 - HOUSE BRAND DENTISTRY | 2024-03-26 PULP FREEZE SPRAY |
| D771412051 - WINTERGREEN FREEZE SPRAY | 2023-11-08 endo freeze spray |
| 10860177000640 - Endodontic Specialists of Northern Colorado Endo Ice | 2019-03-19 Endo Freeze Spray |
| 00860177000636 - Max Pro Medical Freeze Spray | 2018-09-17 Medical Freeze Spray |