| Primary Device ID | 17310231029993 |
| NIH Device Record Key | f3972ab8-76b8-4428-a5ff-f303ca0a4a04 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ProphyCare HAp |
| Version Model Number | 690108 |
| Company DUNS | 353954381 |
| Company Name | Directa AB |
| Device Count | 144 |
| 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 | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +46850650575 |
| info@directadental.com | |
| Phone | +46850650575 |
| info@directadental.com | |
| Phone | +46850650575 |
| info@directadental.com | |
| Phone | +46850650575 |
| info@directadental.com | |
| Phone | +46850650575 |
| info@directadental.com | |
| Phone | +46850650575 |
| info@directadental.com | |
| Phone | +46850650575 |
| info@directadental.com | |
| Phone | +46850650575 |
| info@directadental.com | |
| Phone | +46850650575 |
| info@directadental.com | |
| Phone | +46850650575 |
| info@directadental.com | |
| Phone | +46850650575 |
| info@directadental.com |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 17310231029993 [Unit of Use] |
| GS1 | 17310236901089 [Primary] |
| EJR | Agent, Polishing, Abrasive, Oral Cavity |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-09-09 |
| Device Publish Date | 2025-09-01 |
| 17310237311177 | Blue |
| 17310231029993 | ProphyCare HAp in single dose disposable cups |