| Primary Device ID | 06009544050759 |
| NIH Device Record Key | c3a9cd40-a102-41e2-a32a-7999e2d47063 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | I-SRG-SP |
| 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 | 06009544050759 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[06009544050759]
Moist Heat or Steam Sterilization
[06009544050759]
Moist Heat or Steam Sterilization
[06009544050759]
Moist Heat or Steam Sterilization
[06009544050759]
Moist Heat or Steam Sterilization
[06009544050759]
Moist Heat or Steam Sterilization
[06009544050759]
Moist Heat or Steam Sterilization
[06009544050759]
Moist Heat or Steam Sterilization
[06009544050759]
Moist Heat or Steam Sterilization
[06009544050759]
Moist Heat or Steam Sterilization
[06009544050759]
Moist Heat or Steam Sterilization
[06009544050759]
Moist Heat or Steam Sterilization
[06009544050759]
Moist Heat or Steam Sterilization
[06009544050759]
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 |
| 06009544050742 - NA | 2025-08-07 Guide Screw Remover Ø3.3 Provata |
| 06009544050759 - NA | 2025-08-07Instrument, I-SR6 Screw Remover Guide for SP1 |
| 06009544050759 - NA | 2025-08-07 Instrument, I-SR6 Screw Remover Guide for SP1 |
| 06009544050766 - N/A | 2025-08-07 Instrument, Guided Surgery Fixture Mount for SP1 |
| 06009544050773 - N/A | 2025-08-07 Instrument, Guided Surgery Fixture Mount for SP1, Long |
| 06009544050391 - N/A | 2025-08-06 Spade Twist Drill for SP1, 02.0mm |
| 06009544050407 - N/A | 2025-08-06 Spade Twist Drill for SP1, 02.0mm, Long |
| 06009544050414 - N/A | 2025-08-06 Spade Twist Drill for SP1, 02.0mm |
| 06009544050421 - N/A | 2025-08-06 Spade Twist Drill for SP1, 02.0mm, Long |