| Primary Device ID | 08806388220151 |
| NIH Device Record Key | 20194acc-7541-42a7-8d09-16764cc456d3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | i-Gen Screw |
| Version Model Number | IA1450 |
| Catalog Number | IA1450 |
| 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 | 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 | 08806388220151 [Primary] |
| NHA | Abutment, Implant, Dental, Endosseous |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-11-08 |
| Device Publish Date | 2015-07-27 |
| 08806388220304 | Common M2/ C=5 |
| 08806388220298 | Common M2/ C=4 |
| 08806388220281 | Common M2/ C=3 |
| 08806388220274 | Common M2/ C=2 |
| 08806388220267 | Common M2/ C=1 |
| 08806388220250 | Common M1.8/ C=5 |
| 08806388220243 | Common M1.8/ C=4 |
| 08806388220236 | Common M1.8/ C=3 |
| 08806388220229 | Common M1.8/ C=2 |
| 08806388220212 | Common M1.8/ C=1 |
| 08806388220205 | Common M1.6/ C=5 |
| 08806388220199 | Common M1.6/ C=4 |
| 08806388220182 | Common M1.6/ C=3 |
| 08806388220175 | Common M1.6/ C=2 |
| 08806388220168 | Common M1.6/ C=1 |
| 08806388220151 | Common M1.4/ C=5 |
| 08806388220144 | Common M1.4/ C=4 |
| 08806388220137 | Common M1.4/ C=3 |
| 08806388220120 | Common M1.4/ C=2 |
| 08806388220113 | Common M1.4/ C=1.5 |