| Primary Device ID | 06009544038306 |
| NIH Device Record Key | a8a62cb6-cca0-483f-a328-99e3677d2c80 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | I-L43-12D-GS |
| 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 | 06009544038306 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[06009544038306]
Moist Heat or Steam Sterilization
[06009544038306]
Moist Heat or Steam Sterilization
[06009544038306]
Moist Heat or Steam Sterilization
[06009544038306]
Moist Heat or Steam Sterilization
[06009544038306]
Moist Heat or Steam Sterilization
[06009544038306]
Moist Heat or Steam Sterilization
[06009544038306]
Moist Heat or Steam Sterilization
[06009544038306]
Moist Heat or Steam Sterilization
[06009544038306]
Moist Heat or Steam Sterilization
[06009544038306]
Moist Heat or Steam Sterilization
[06009544038306]
Moist Heat or Steam Sterilization
[06009544038306]
Moist Heat or Steam Sterilization
[06009544038306]
Moist Heat or Steam Sterilization
[06009544038306]
Moist Heat or Steam Sterilization
[06009544038306]
Moist Heat or Steam Sterilization
[06009544038306]
Moist Heat or Steam Sterilization
[06009544038306]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-01-30 |
| Device Publish Date | 2025-01-22 |
| 06009544025504 - N/A | 2025-04-14 Post Access Maintainer 1.22 |
| 06009544027638 - N/A | 2025-04-10 Resorbable collagen membrane 15x20mm |
| 06009544027645 - N/A | 2025-04-10 Resorbable collagen membrane 20x30mm |
| 06009544027652 - N/A | 2025-04-10 Resorbable collagen membrane 30x40mm |
| 06009544027669 - N/A | 2025-04-10 Bone matrix, porcine cancellous fine 0.5cc |
| 06009544027676 - N/A | 2025-04-10 Bone matrix, porcine cancellous fine 1.0cc |
| 06009544027683 - N/A | 2025-04-10 Bone matrix, porcine cancellous fine 2.0cc |
| 06009544027690 - N/A | 2025-04-10 Bone matrix, porcine cancellous std 2.0cc |