| Primary Device ID | 08809985663444 |
| NIH Device Record Key | bb13b347-36bd-4b8f-806c-dab3b07ab1bc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Angle Guide Tool |
| Version Model Number | AXARINAGT20 |
| Catalog Number | AXARINAGT20 |
| 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 | 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 | 08809985663444 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08809985663444]
Moist Heat or Steam Sterilization
[08809985663444]
Moist Heat or Steam Sterilization
[08809985663444]
Moist Heat or Steam Sterilization
[08809985663444]
Moist Heat or Steam Sterilization
[08809985663444]
Moist Heat or Steam Sterilization
[08809985663444]
Moist Heat or Steam Sterilization
[08809985663444]
Moist Heat or Steam Sterilization
[08809985663444]
Moist Heat or Steam Sterilization
[08809985663444]
Moist Heat or Steam Sterilization
[08809985663444]
Moist Heat or Steam Sterilization
[08809985663444]
Moist Heat or Steam Sterilization
[08809985663444]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-08-07 |
| Device Publish Date | 2024-07-30 |
| 08809985663512 | AXBDNAGT10 |
| 08809985663505 | AXBDNAGT20 |
| 08809985663499 | AXBDNAGT30 |
| 08809985663482 | AXBDRAGT10 |
| 08809985663475 | AXBDRAGT20 |
| 08809985663468 | AXBDRAGT30 |
| 08809985663451 | AXARINAGT10 |
| 08809985663444 | AXARINAGT20 |
| 08809985663437 | AXARINAGT30 |
| 08809985664922 | XPEED AnyRidge Internal Implant System |
| 08809985664915 | XPEED AnyRidge Internal Implant System |
| 08809985664908 | XPEED AnyRidge Internal Implant System |
| 08800293008972 | Hex 2.1 |
| 08800293008965 | Hex 2.1 |
| 08800293008958 | Octa 2.5 |
| 08800293008941 | Octa 2.5 |
| 08800293008934 | Octa 2.1 |
| 08800293008927 | Octa 2.1 |
| 08800293008910 | Hex 2.5 |
| 08800293008903 | Hex 2.5 |
| 08800293008897 | Hex 2.3 |
| 08800293008880 | Hex 2.3 |
| 08800293003823 | Hex 2.5 |
| 08800293003816 | Hex 2.5 |
| 08800293003809 | Hex 2.5 |