| Primary Device ID | 06009544001164 |
| NIH Device Record Key | fe899468-ebcf-4434-bd9d-d5880ac27244 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | BAT11.5 |
| Company DUNS | 636239584 |
| Company Name | SOUTHERN IMPLANTS (PTY) LTD |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06009544001164 [Primary] |
| DZE | Implant, Endosseous, Root-Form |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-02-22 |
| Device Publish Date | 2019-01-22 |
| 06009544047605 - N/A | 2024-08-09 Instrument WI tool SP1 Large |
| 06009544047797 - N/A | 2024-08-09 Guided Surgery HP Insertion Tool for Ø3.3 Provata® |
| 06009544048015 - NA | 2024-07-24 Instrument Tray Pterygoid Milled |
| 06009544037491 - N/A | 2024-06-18 Screw PA Abut PRO M1.6 Titanium |
| 06009544038276 - N/A | 2024-06-18 Screw PA Abut PRO M16 Brass |
| 06009544045274 - N/A | 2024-06-07 Implant Inverta MSc DC30 Ø3.75x8 |
| 06009544045281 - N/A | 2024-06-07 Implant Inverta MSc DC30 Ø3.75x10 |
| 06009544045298 - N/A | 2024-06-07 Implant Inverta MSc DC30 Ø3.75x13 |