| Primary Device ID | 08806388218080 |
| NIH Device Record Key | ae6301a6-f59f-4e1a-935a-8ac61603fd85 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Flat Cover screw |
| Version Model Number | FCS3510 |
| Catalog Number | FCS3510 |
| Company DUNS | 687388178 |
| Company Name | Megagen Implant Co. 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 | true |
| 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 | 08806388218080 [Primary] |
| NHA | Abutment, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08806388218080]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-11-08 |
| Device Publish Date | 2015-06-24 |
| 08809977452049 - N2 | 2024-04-10 |
| 08809931183798 - Open Wrench | 2024-03-20 ARi ExCon Implant System |
| 08809822761821 - TiGEN Abutment | 2024-02-28 ARi ExCon Implant System |
| 08809822761937 - ZrGEN Abutment | 2024-02-28 ARi ExCon Implant System |
| 08809822762002 - ZrGEN Abutment | 2024-02-28 ARi ExCon Implant System |
| 08809822762019 - TiGEN Abutment | 2024-02-28 ARi ExCon Implant System |
| 08809822762101 - ZrGEN Abutment | 2024-02-28 ARi ExCon Implant System |
| 08809822762125 - ZrGEN Abutment | 2024-02-28 ARi ExCon Implant System |