| Primary Device ID | 06009544038313 |
| NIH Device Record Key | b07ba74b-8c7d-40d7-849d-10eed151e601 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | I-L50-12D-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 | 06009544038313 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[06009544038313]
Moist Heat or Steam Sterilization
[06009544038313]
Moist Heat or Steam Sterilization
[06009544038313]
Moist Heat or Steam Sterilization
[06009544038313]
Moist Heat or Steam Sterilization
[06009544038313]
Moist Heat or Steam Sterilization
[06009544038313]
Moist Heat or Steam Sterilization
[06009544038313]
Moist Heat or Steam Sterilization
[06009544038313]
Moist Heat or Steam Sterilization
[06009544038313]
Moist Heat or Steam Sterilization
[06009544038313]
Moist Heat or Steam Sterilization
[06009544038313]
Moist Heat or Steam Sterilization
[06009544038313]
Moist Heat or Steam Sterilization
[06009544038313]
Moist Heat or Steam Sterilization
[06009544038313]
Moist Heat or Steam Sterilization
[06009544038313]
Moist Heat or Steam Sterilization
[06009544038313]
Moist Heat or Steam Sterilization
[06009544038313]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-03-20 |
| Device Publish Date | 2025-03-12 |
| 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 |