| Primary Device ID | 07350081495077 |
| NIH Device Record Key | a0615ec7-998d-4725-ada0-64a304f43d95 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Anew Implant System |
| Version Model Number | ST-18S |
| Company DUNS | 355803412 |
| Company Name | Dentatus AB |
| Device Count | 1 |
| 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 | +46854650900 |
| info@dentatus.se |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07350081494650 [Package] Package: Implant pack [2 Units] In Commercial Distribution |
| GS1 | 07350081494667 [Package] Package: Implant pack [1 Units] In Commercial Distribution |
| GS1 | 07350081495077 [Primary] |
| DZE | Implant, Endosseous, Root-Form |
| 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 | 2015-08-20 |
| 07350081495138 | Dentatus Anew Implant |
| 07350081495121 | Dentatus Anew Implant, blister pack including 1 pc |
| 07350081495114 | Dentatus Anew Implant, blister pack including 1 pc |
| 07350081495107 | Dentatus Anew Implant, blister pack including 1 pc |
| 07350081495091 | Dentatus Anew Implant, blister pack including 1 pc |
| 07350081495084 | Dentatus Anew Implant, blisterpack including 1 pc |
| 07350081495077 | Dentatus Anew Implant, blister pack including 1 pc |
| 07350081495060 | Dentatus Anew Implant, blister pack including 1 pc |
| 07350081495053 | Dentatus Anew Implant, blister pack including 1 pc |
| 07350081495343 | Dentatus Anew Implant, blister pack including 1 pc |