| Primary Device ID | 06009544050339 |
| NIH Device Record Key | 7bb51290-b6fb-4ba1-abe3-bd042d509d82 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | I-BM-SP-70 |
| 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 | 06009544050339 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[06009544050339]
Moist Heat or Steam Sterilization
[06009544050339]
Moist Heat or Steam Sterilization
[06009544050339]
Moist Heat or Steam Sterilization
[06009544050339]
Moist Heat or Steam Sterilization
[06009544050339]
Moist Heat or Steam Sterilization
[06009544050339]
Moist Heat or Steam Sterilization
[06009544050339]
Moist Heat or Steam Sterilization
[06009544050339]
Moist Heat or Steam Sterilization
[06009544050339]
Moist Heat or Steam Sterilization
[06009544050339]
Moist Heat or Steam Sterilization
[06009544050339]
Moist Heat or Steam Sterilization
[06009544050339]
Moist Heat or Steam Sterilization
[06009544050339]
Moist Heat or Steam Sterilization
[06009544050339]
Moist Heat or Steam Sterilization
[06009544050339]
Moist Heat or Steam Sterilization
[06009544050339]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-04-07 |
| Device Publish Date | 2025-03-28 |
| 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 |
| 06009544048961 - ZAGA™ | 2025-04-23 Straumann® Zygomatic Implant, Implant Zaga Flat 35.0mm |
| 06009544048978 - ZAGA™ | 2025-04-23 Straumann® Zygomatic Implant, Implant Zaga Flat 37.6mm |
| 06009544048985 - ZAGA™ | 2025-04-23 Straumann® Zygomatic Implant, Implant Zaga Flat 40.0mm |
| 06009544048992 - ZAGA™ | 2025-04-23 Straumann® Zygomatic Implant, Implant Zaga Flat 42.5mm |
| 06009544049005 - ZAGA™ | 2025-04-23 Straumann® Zygomatic Implant, Implant Zaga Flat 45.0mm |
| 06009544049012 - ZAGA™ | 2025-04-23 Straumann® Zygomatic Implant, Implant Zaga Flat 47.5mm |