| Primary Device ID | 06009544050346 |
| NIH Device Record Key | c7c149a3-434f-4900-853b-1bc4b1eb3309 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | I-BMZYG-CAP |
| Company DUNS | 636239584 |
| Company Name | SOUTHERN IMPLANTS (PTY) LTD |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| 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 | 06009544050346 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[06009544050346]
Moist Heat or Steam Sterilization
[06009544050346]
Moist Heat or Steam Sterilization
[06009544050346]
Moist Heat or Steam Sterilization
[06009544050346]
Moist Heat or Steam Sterilization
[06009544050346]
Moist Heat or Steam Sterilization
[06009544050346]
Moist Heat or Steam Sterilization
[06009544050346]
Moist Heat or Steam Sterilization
[06009544050346]
Moist Heat or Steam Sterilization
[06009544050346]
Moist Heat or Steam Sterilization
[06009544050346]
Moist Heat or Steam Sterilization
[06009544050346]
Moist Heat or Steam Sterilization
[06009544050346]
Moist Heat or Steam Sterilization
[06009544050346]
Moist Heat or Steam Sterilization
[06009544050346]
Moist Heat or Steam Sterilization
[06009544050346]
Moist Heat or Steam Sterilization
[06009544050346]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-04-07 |
| Device Publish Date | 2025-03-28 |
| 06009544047810 - N/A | 2025-11-25 Titanium Blank for Ø3.3 Provata®, Ø11.5mm |
| 06009544047827 - N/A | 2025-11-25 Titanium Blank for Ø3.0 DC, Ø11.5mm |
| 06009544047834 - N/A | 2025-11-25 Titanium Blank for Ø3.5/Ø4.0 DC, Ø11.5mm |
| 06009544047841 - N/A | 2025-11-25 Titanium Blank for Ø5.0 DC , Ø11.5mm |
| 06009544047858 - N/A | 2025-11-25 Titanium Blank for Ø3.5 Tri-Nex, Ø11.5mm |
| 06009544047865 - N/A | 2025-11-25 Titanium Blank for Ø4.3 Tri-Nex, Ø11.5mm |
| 06009544047872 - N/A | 2025-11-25 Titanium Blank for Ø5.0 Tri-Nex, Ø11.5mm |
| 06009544047889 - N/A | 2025-11-25 Titanium Blank for Ø6.0 Tri-Nex, Ø11.5mm |