| Primary Device ID | 06009544026846 |
| NIH Device Record Key | cc7dc298-6833-4839-8c9d-742fece1b430 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Provata Co-Axis™ |
| Version Model Number | PRO12D413 |
| 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 | 06009544026846 [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 | 2019-02-11 |
| Device Publish Date | 2019-01-10 |
| 06009544026921 | Internal Hex 12° Co-Axis Implant, Ø5.0 x 18mm |
| 06009544026914 | Internal Hex 12° Co-Axis Implant, Ø5.0 x 15mm |
| 06009544026907 | Internal Hex 12° Co-Axis Implant, Ø5.0 x 13mm |
| 06009544026891 | Internal Hex 12° Co-Axis Implant, Ø5.0 x 11.5mm |
| 06009544026884 | Internal Hex 12° Co-Axis Implant, Ø5.0 x 10mm |
| 06009544026877 | Internal Hex 12° Co-Axis Implant, Ø5.0 x 8.5mm |
| 06009544026860 | Internal Hex 12° Co-Axis Implant, Ø4.0 x 18mm |
| 06009544026853 | Internal Hex 12° Co-Axis Implant, Ø4.0 x 15mm |
| 06009544026846 | Internal Hex 12° Co-Axis Implant, Ø4.0 x 13mm |
| 06009544026839 | Internal Hex 12° Co-Axis Implant, Ø4.0 x 11.5mm |
| 06009544026822 | Internal Hex 12° Co-Axis Implant, Ø4.0 x 10mm |
| 06009544026815 | Internal Hex 12° Co-Axis Implant, Ø4.0 x 8.5mm |