| Primary Device ID | 08806388219643 |
| NIH Device Record Key | ac3bf9e3-893d-41bb-a860-85b04224e932 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Gold Abutment |
| Version Model Number | GA4515H |
| Catalog Number | GA4515HT |
| 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 | 08806388219643 [Primary] |
| NHA | Abutment, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08806388219643]
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 | 2015-06-25 |
| 08806388241477 | Rescue External Hex/ Widecone |
| 08806388240449 | ExFeel External Hex/ Wide |
| 08806388240432 | ExFeel External Non-Hex/ Wide |
| 08806388236985 | ExFeel External Hex/ Small |
| 08806388236978 | ExFeel External Non-Hex/ Small |
| 08806388234110 | ExFeel External Hex/ Regular |
| 08806388234103 | ExFeel External Non-Hex/ Regular |
| 08806388233267 | ExFeel External C=2 |
| 08806388233250 | ExFeel External C=1 |
| 08806388233243 | Rescue External Ø6/ Hex |
| 08806388233236 | Rescue External Ø6/ Non-Hex |
| 08806388232475 | ExFeel External Hex |
| 08806388232468 | ExFeel External Non-Hex |
| 08806388225149 | Rescue External Ø5/ Hex |
| 08806388225132 | Rescue External Ø5/ Non-Hex |
| 08806388222094 | ExFeel Internal Octa |
| 08806388222087 | ExFeel Internal Non-Octa |
| 08806388219650 | AnyOne Internal Ø4.5/ L=12/ Non-Hex |
| 08806388219643 | AnyOne Internal Ø4.5/ L=12/ Hex |
| 08806388214976 | EZ Plus Internal Trip/ Small |
| 08806388214969 | EZ Plus Internal Non-Trip/ Small |
| 08806388208975 | Rescue Internal Trip |
| 08806388208968 | Rescue Internal Non-Trip |
| 08806388207220 | EZ Plus Internal Trip |
| 08806388207206 | EZ Plus Internal Non-Hex |
| 08806388215416 | Exfeel Internal Octa |
| 08806388215409 | Exfeel Internal Non-Octa |
| 08809708752349 | IOGO100 |
| 08806388201976 | Ø4/ Non-Hex |
| 08806388201969 | Ø4/ Hex |