| Primary Device ID | 06009544019459 |
| NIH Device Record Key | 08d8d305-a704-43ec-87b3-54b5fb423ce4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SB16PH |
| Version Model Number | 6009544019459 |
| 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 | 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 | 06009544019459 [Primary] |
| NHA | Abutment, Implant, Dental, Endosseous |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-03-28 |
| Device Publish Date | 2022-03-19 |
| 06009544048671 - NA | 2024-12-19 Implant ExHex Wide ZYGIN Ø4.3x30mm |
| 06009544048688 - NA | 2024-12-19 Implant ExHex Wide ZYGIN Ø4.3x32.5mm |
| 06009544048695 - NA | 2024-12-19 Implant ExHex Wide ZYGIN Ø4.3x35mm |
| 06009544048701 - NA | 2024-12-19 Implant ExHex Wide ZYGIN Ø4.3x37.5mm |
| 06009544048718 - NA | 2024-12-19 Implant ExHex Wide ZYGIN Ø4.3x40mm |
| 06009544048725 - NA | 2024-12-19 Implant ExHex Wide ZYGIN Ø4.3x42.5mm |
| 06009544048732 - NA | 2024-12-19 Implant ExHex Wide ZYGIN Ø4.3x45mm |
| 06009544048749 - NA | 2024-12-19 Implant ExHex Wide ZYGIN Ø4.3x47.5mm |