Primary Device ID | 08806388240012 |
NIH Device Record Key | 5b3069f3-fbdb-4176-b929-9d5dd7b0ec3e |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Twist Drill |
Version Model Number | TMID2012 |
Catalog Number | TMID2012 |
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 | 08806388240012 [Primary] |
NDP | Accessories, Implant, Dental, Endosseous |
Steralize Prior To Use | true |
Device Is Sterile | false |
[08806388240012]
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 |