| Primary Device ID | 06009544048923 |
| NIH Device Record Key | 517a518d-9c77-4201-9b95-c32fdeed84e3 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | ZYGON-60 |
| Company DUNS | 636239584 |
| Company Name | SOUTHERN IMPLANTS (PTY) LTD |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 | 06009544048923 [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 | 2024-12-19 |
| Device Publish Date | 2024-12-11 |
| 06009544050568 - N/A | 2025-07-24 V2-GC-90772 |
| 06009544050643 - N/A | 2025-07-24 Instrument Tray for Zygomatic, Large |
| 06009544000105 - NA | 2025-07-17 Abutment Healing Int Hex PM 6.5x6 |
| 06009544050438 - N/A | 2025-07-17 Abutment Healing SP1 ø3.8x2.5mm |
| 06009544050445 - N/A | 2025-07-17 Abutment Healing SP1 ø3.8x3.5mm |
| 06009544050452 - N/A | 2025-07-17 Abutment Healing SP1 ø3.8x4.5mm |
| 06009544050469 - N/A | 2025-07-17 Abutment Healing SP1 ø3.8x5.5mm |
| 06009544050476 - N/A | 2025-07-17 Abutment Healing SP1 ø3.8x6.5mm |