| Primary Device ID | 06009544038252 |
| NIH Device Record Key | 48c03f4b-947c-4395-8373-8e255eb79c86 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | S-TSH1-35L |
| 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 | 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 | 06009544038252 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-06 |
| Device Publish Date | 2024-10-29 |
| 06009544026266 - NA | 2025-12-29 Torx Titanium Screw for IT, Angulated Screw Channel |
| 06009544050919 - N/A | 2025-12-29 Angulated Screw Channel Abutment, Engaging, for Ø5.0 DC |
| 06009544050926 - N/A | 2025-12-29 Angulated Screw Channel Abutment, Engaging, for IT |
| 06009544050957 - N/A | 2025-12-26 Guided Surgery Sleeve, OD Ø5.1 / ID Ø4.2 x 4mm |
| 06009544050964 - N/A | 2025-12-26 Guided Surgery Sleeve, OD Ø5.2 / ID Ø4.2 x 6mm |
| 06009544050971 - N/A | 2025-12-26 Guided Surgery Sleeve, OD Ø6.2 / ID Ø5.2 x 4mm |
| 06009544050988 - N/A | 2025-12-26 Guided Surgery Sleeve, OD Ø6.2 / Ø5.2 x 6mm |
| 06009544050995 - N/A | 2025-12-26 Guided Surgery Sleeve, OD Ø6.2 / ID Ø5.2 x 4mm, Multipack x5 |