| Primary Device ID | 06009544050742 |
| NIH Device Record Key | b2c8dcbb-a4b3-4978-ab14-8ad42786743e |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | I-SRG-3M |
| 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 | 06009544050742 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[06009544050742]
Moist Heat or Steam Sterilization
[06009544050742]
Moist Heat or Steam Sterilization
[06009544050742]
Moist Heat or Steam Sterilization
[06009544050742]
Moist Heat or Steam Sterilization
[06009544050742]
Moist Heat or Steam Sterilization
[06009544050742]
Moist Heat or Steam Sterilization
[06009544050742]
Moist Heat or Steam Sterilization
[06009544050742]
Moist Heat or Steam Sterilization
[06009544050742]
Moist Heat or Steam Sterilization
[06009544050742]
Moist Heat or Steam Sterilization
[06009544050742]
Moist Heat or Steam Sterilization
[06009544050742]
Moist Heat or Steam Sterilization
[06009544050742]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-08-07 |
| Device Publish Date | 2025-07-30 |
| 06009544050575 - N/A | 2025-08-19 Implant DR SP1 Ø3.7x10mm |
| 06009544050582 - N/A | 2025-08-19 Implant DR SP1 Ø3.7x8mm |
| 06009544050599 - N/A | 2025-08-19 Implant DR SP1 Ø3.7x11mm |
| 06009544050605 - N/A | 2025-08-19 Implant DR SP1 Ø3.7x13mm |
| 06009544050612 - N/A | 2025-08-19 Implant DR SP1 Ø3.7x16mm |
| 06009544050629 - N/A | 2025-08-19 Implant DR SP1 Ø3.7x18mm |
| 06009544050636 - N/A | 2025-08-19 Implant DR SP1 Ø3.7x20mm |
| 06009544050650 - N/A | 2025-08-19 Implant DR SP1 Ø4.5x8mm |