| Primary Device ID | 06009544021254 |
| NIH Device Record Key | 04306c1f-b12a-43c3-931f-3933b0864a41 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | TBE8N |
| Company DUNS | 636239584 |
| Company Name | SOUTHERN IMPLANTS (PTY) LTD |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | 06009544021254 [Primary] |
| FZE | Prosthesis, Nose, Internal |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-02-18 |
| Device Publish Date | 2019-01-17 |
| 06009544023975 - N/A | 2024-05-10 Ext. Hex Reduced Platform Implant, 36°, Ø5.0 x 10mm |
| 06009544023982 - N/A | 2024-05-10 Ext. Hex Reduced Platform Implant, 36°, Ø5.0 x 11.5mm |
| 06009544023999 - N/A | 2024-05-10 Ext. Hex Reduced Platform Implant, 36°, Ø5.0 x 13mm |
| 06009544024002 - N/A | 2024-05-10 Ext. Hex Reduced Platform Implant, 36°, Ø5.0 x 15mm |
| 06009544024019 - N/A | 2024-05-10 Ext. Hex Reduced Platform Implant, 36°, Ø5.0 x 18mm |
| 06009544024026 - N/A | 2024-05-10 Ext. Hex Reduced Platform Implant, 36°, Ø5.0 x 8.5mm |
| 06009544026358 - Co-Axis™ | 2024-05-10 Ext. Hex Reduced Platform Implant, 36° Co-Axis™, Ø4.0 x 8.5mm |
| 06009544044024 - Co-Axis™ | 2024-05-10 Ext. Hex Reduced Platform MSC Implant, 36° Co-Axis™, Ø4.0 x 20mm |