| Primary Device ID | 06009544049197 |
| NIH Device Record Key | cc311f2a-7479-413b-b966-2551877c06ed |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | N/A |
| Version Model Number | D-CB25-BG |
| 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 | false |
| 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 | 06009544049197 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[06009544049197]
Moist Heat or Steam Sterilization
[06009544049197]
Moist Heat or Steam Sterilization
[06009544049197]
Moist Heat or Steam Sterilization
[06009544049197]
Moist Heat or Steam Sterilization
[06009544049197]
Moist Heat or Steam Sterilization
[06009544049197]
Moist Heat or Steam Sterilization
[06009544049197]
Moist Heat or Steam Sterilization
[06009544049197]
Moist Heat or Steam Sterilization
[06009544049197]
Moist Heat or Steam Sterilization
[06009544049197]
Moist Heat or Steam Sterilization
[06009544049197]
Moist Heat or Steam Sterilization
[06009544049197]
Moist Heat or Steam Sterilization
[06009544049197]
Moist Heat or Steam Sterilization
[06009544049197]
Moist Heat or Steam Sterilization
[06009544049197]
Moist Heat or Steam Sterilization
[06009544049197]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-01-28 |
| Device Publish Date | 2025-01-20 |
| 06009544036845 | Instrument Zyg Z Depth Gauge |
| 06009544036821 | Instr Direction Indicator IV |
| 06009544036814 | Instr Direction Indicator 12° IV |
| 06009544035411 | Driver Drill Guide Rohner Tech |
| 06009544031918 | Passive Abutment for Int. Hex, Engaging, Ø4.5 Platform Match |
| 06009544029847 | Plastic Sleeve for Int. Hex Passive Abutment, Engaging |
| 06009544029830 | Titanium Cylinder for Int. Hex Passive Abutment, Engaging |
| 06009544029823 | Titanium Cylinder for Int. Hex Passive Abutment, Non-Engaging |
| 06009544028499 | Titanium Cylinder for Ø5.0 DC Passive Abutment, Non-Engaging |
| 06009544028482 | Titanium Cylinder for Ø3.5 / Ø4.0 DC Passive Abutment, Non-Engaging |
| 06009544028475 | Titanium Cylinder for Ø3.0 DC Passive Abutment, Non-Engaging |
| 06009544028468 | Plastic Sleeve for Ø5.0 DC Passive Abutment, Non-Engaging |
| 06009544028451 | Plastic Sleeve for Ø3.5 / Ø4.0 DC Passive Abutment, Non-Engaging |
| 06009544028444 | Plastic Sleeve for Ø3.0 DC Passive Abutment, Non-Engaging |
| 06009544027997 | Passive Abutment for Int. Hex, Engaging |
| 06009544027980 | Passive Abutment for Int. Hex, Non-Engaging |
| 06009544027959 | Titanium Abutment for Int. Hex, Non-Engaging, 3mm Cuff |
| 06009544027942 | Titanium Abutment for Int. Hex, Non-Engaging, 1mm Cuff |
| 06009544027935 | Titanium Abutment for Int. Hex, Engaging, 3mm Cuff |
| 06009544027928 | Titanium Abutment for Int. Hex, Engaging, 1mm Cuff |
| 06009544022107 | Titanium Abutment, Smooth, for Ø4.8 Compact Conical |
| 06009544021643 | Vertical Titanium Abutment, Non-Engaging, for Ø5.0 Ex Hex, 1mm Cuff |
| 06009544021636 | Vertical Titanium Abutment, Engaging, for Ø5.0 Ex Hex, 1mm Cuff |
| 06009544020509 | Passive Abutment, Non-Engaging, for Max9 Ex Hex |
| 06009544020493 | Passive Abutment, Engaging, for Max9 Ex Hex |
| 06009544019770 | Vertical Passive Abutment, Engaging, for Ø3.25 Ex Hex |
| 06009544019756 | Titanium Cylinder for Ø3.25 Ex Hex Passive Abutment, Non-Engaging |
| 06009544019749 | Passive Abutment, Non-Engaging, for Ø3.25 Ex Hex |
| 06009544019725 | Titanium Cylinder for Ø3.25 Ex Hex Passive Abutment, Engaging |
| 06009544019701 | Passive Abutment, Engaging, for Ø3.25 Ex Hex |
| 06009544019657 | Titanium Cylinder for Ø6.0 Ex Hex Passive Abutment, Non-Engaging |
| 06009544019640 | Passive Abutment, Non-Engaging, for Ø6.0 Ex Hex |
| 06009544019633 | Plastic Sleeve for Ø6.0 Ex Hex Passive Abutment, Non-Engaging |
| 06009544019626 | Titanium Cylinder for Ø6.0 Ex Hex Passive Abutment, Engaging |
| 06009544019619 | Plastic Sleeve for Ø6.0 Ex Hex Passive Abutment, Engaging |
| 06009544019602 | Passive Abutment, Engaging, for Ø6.0 Ex Hex |
| 06009544019572 | Titanium Cylinder for Ø5.0 Ex Hex Passive Abutment, Non-Engaging |
| 06009544019565 | Passive Abutment, Non-Engaging, for Ø5.0 Ex Hex |
| 06009544019558 | Plastic Sleeve for Ø5.0 Ex Hex Passive Abutment, Non-Engaging |
| 06009544019541 | Titanium Cylinder for Ø5.0 Ex Hex Passive Abutment, Engaging |
| 06009544019534 | Plastic Sleeve for Ø5.0 Ex Hex Passive Abutment, Engaging |
| 06009544019527 | Passive Abutment, Engaging, for Ø5.0 Ex Hex |
| 06009544019497 | Titanium Cylinder for Ø4.0 Ex Hex Passive Abutment, Non-Engaging |
| 06009544019473 | Plastic Sleeve for Ø4.0 Ex Hex Passive Abutment, Non-Engaging |
| 06009544019466 | Titanium Cylinder for Ø4.0 Ex Hex Passive Abutment, Engaging |
| 06009544018391 | Titanium Cylinder for Int. Hex Passive Abutment, Non-Engaging |
| 06009544018384 | Plastic Sleeve for Int. Hex Passive Abutment, Non-Engaging |
| 06009544018377 | Passive Abutment for Int. Hex, Non-Engaging |
| 06009544018360 | Titanium Cylinder for Ø6.0 Tri-Nex Passive Abutment, Non-Engaging |
| 06009544018353 | Plastic Sleeve for Ø6.0 Tri-Nex Passive Abutment, Non-Engaging |