| 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
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-01-30 |
| Device Publish Date | 2025-01-22 |
| 06009544041450 - N/A | 2025-01-31 Scan Flag Ti ø3.3 PRO |
| 06009544038306 - NA | 2025-01-30Handpiece Insertion Tool for Ø4.3 Tri-Nex Co-Axis Guided Surgery |
| 06009544038306 - NA | 2025-01-30 Handpiece Insertion Tool for Ø4.3 Tri-Nex Co-Axis Guided Surgery |
| 06009544038955 - NA | 2025-01-30 Sleeve Guided Surgery 06.2 x 4mm |
| 06009544048930 - N/A | 2025-01-28 Instr Drill Ext GS ø5.1 Offset 10.5 |
| 06009544049074 - N/A | 2025-01-28 Insertion Tool Int Hex BG |
| 06009544049098 - N/A | 2025-01-28 Instr H/P Insert Tool PRO3 BG |
| 06009544049104 - N/A | 2025-01-28 Instr H/P Insert Tool PRO3 BGN |
| 06009544049111 - N/A | 2025-01-28 Insertion Tool Int Hex BGN |