| Primary Device ID | 06009544004929 |
| NIH Device Record Key | 9720733d-fab1-46b6-a583-f8e7e30738b2 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | DCT3513 |
| 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 | 06009544004929 [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 | 2019-01-07 |
| Device Publish Date | 2018-12-05 |
| 06009544038252 - NA | 2024-11-06 Screw Ti Hex Series L3.5mm |
| 06009544039952 - N/A | 2024-11-01 Screw Titanium Hex 1 Series ø2.7 Head |
| 06009544039969 - N/A | 2024-11-01 Screw Ti Hexed M1.4 NLT |
| 06009544048589 - N/A | 2024-09-03 Implant SP1 Ø4.0x10mm |
| 06009544048596 - N/A | 2024-09-03 Implant SP1 Ø4.0x11mm |
| 06009544048619 - N/A | 2024-09-03 Implant SP1 Ø4.0x15mm |
| 06009544048626 - N/A | 2024-09-03 Implant SP1 Ø4.0x18mm |
| 06009544048633 - N/A | 2024-09-03 Implant SP1 Ø4.0x20mm |