| Primary Device ID | 08806388239207 |
| NIH Device Record Key | 527f9824-1f58-4ce5-895e-807c7975d26d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Twist Drill |
| Version Model Number | TEED2011 |
| Catalog Number | TEED2011 |
| Company DUNS | 687388178 |
| Company Name | Megagen Implant Co. 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 | 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 | 08806388239207 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08806388239207]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-01-09 |
| Device Publish Date | 2015-06-24 |
| 08806388240029 | MegaFix Ø2/ L=14/ Stopper |
| 08806388240012 | MegaFix Ø2/ L=12/ Stopper |
| 08806388240005 | MegaFix Ø2/ L=10/ Stopper |
| 08806388239993 | MegaFix Ø2/ L=18.5 |
| 08806388239986 | MegaFix Ø2/ L=8/ Stopper |
| 08806388239979 | MegaFix Ø2/ L=7/ Stopper |
| 08806388239955 | MegaFix Ø4.9/ L=10 |
| 08806388239948 | MegaFix Ø4.9/ L=18 |
| 08806388239931 | MegaFix Ø4.4/ L=18 |
| 08806388239924 | MegaFix Ø3.9/ L=18 |
| 08806388239917 | MegaFix Ø3.35/ L=18 |
| 08806388239900 | MegaFix Ø2.95/ L=18 |
| 08806388239894 | MegaFix Ø2/ L=18 |
| 08806388239207 | Common Ø2/ L=11.5/ Stopper |
| 08806388239191 | Common Ø2/ L=10/ Stopper |
| 08806388239184 | Common Ø2/ L=12/ Short |
| 08806388239177 | Common Ø2/ L=18.5 |
| 08806388239160 | Common Ø2/ L=8.5/ Stopper |
| 08806388239153 | Common Ø2/ L=7/ Stopper |
| 08806388229024 | Common Ø4.8/ L=12 |
| 08806388229017 | Common Ø3.5/ L=12 |
| 08806388229000 | Common Ø3/ L=18.5 |
| 08806388228621 | Rescue Ø4.8/ L=12.5 |
| 08806388228614 | Rescue Ø4.3/ L=12.5 |
| 08806388228607 | Rescue Ø3.8/ L=12.5 |
| 08806388228591 | Rescue Ø3.3/ L=12.5 |
| 08806388228584 | Rescue Ø2.8/ L=12.5 |
| 08806388228577 | Rescue Ø2.0/ L=12.5 |