| Primary Device ID | EDET044161 |
| NIH Device Record Key | c726dd08-1515-44e2-8664-9e5bde3bd629 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Primeprint Splint SF 1000g |
| Version Model Number | 04416 |
| Company DUNS | 343947949 |
| Company Name | DETAX GmbH |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | EDET044161 [Primary] |
| DYJ | Retainer, Screw Expansion, Orthodontic |
| KMY | Positioner, Tooth, Preformed |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-11-02 |
| Device Publish Date | 2023-10-25 |
| EDET025231 - addition ultra automix 2 | 2024-09-05 |
| EDET028921 - bioplast 25 shore 8 x 50ml | 2024-09-05 |
| EDET031591 - mixing cannulas optima lilac 50 pcs. | 2024-09-05 |
| EDET031601 - mixing cannulas optima lilac 100 pcs. | 2024-09-05 |
| EDET033491 - aquaplus colormix yellow 8 x 50 ml | 2024-09-05 |
| EDET033501 - aquaplus colormix green8 x 50 ml | 2024-09-05 |
| EDET033541 - aquaplus colormix orange 8 x 50 ml | 2024-09-05 |
| EDET037391 - addition supra automix 2 8x50ml | 2024-09-05 |