| Primary Device ID | 06009544021872 |
| NIH Device Record Key | 046ae73e-28c1-49e2-acc9-aa14f56faf50 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | TCMAX9-1NH |
| 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 | 06009544021872 [Primary] |
| NHA | Abutment, Implant, Dental, Endosseous |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-11-08 |
| Device Publish Date | 2019-01-11 |
| 06009544040064 - N/A | 2025-05-05 Instr H/P Oct Int Drive GS |
| 06009544012115 - N/A | 2025-05-02 Converter and Extention Instr |
| 06009544039990 - N/A | 2025-05-02 Instrument Space Maintainer CC 4.8x6 |
| 06009544040774 - N/A | 2025-05-02 O-Ring DC3 Insertion Tools MP5 |
| 06009544050353 - NA | 2025-05-01 Compact Conical Abutment for 17° Ø4 ExHex Ø4.8x3mm |
| 06009544050360 - NA | 2025-05-01 Compact Conical Abutment for 17° Ø4 ExHex Ø4.8x4mm |
| 06009544048947 - ZAGA™ | 2025-04-23 Straumann® Zygomatic Implant, Implant Zaga Flat 30.0mm |
| 06009544048954 - ZAGA™ | 2025-04-23 Straumann® Zygomatic Implant, Implant Zaga Flat 32.5mm |