| Primary Device ID | 08809985664922 | 
| NIH Device Record Key | 74bc79c6-baeb-4dd6-ad54-efc92f86193c | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Angle Guide Tool | 
| Version Model Number | AXARAGT30 | 
| Catalog Number | AXARAGT30 | 
| 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 | 08809985664922 [Primary] | 
| NDP | Accessories, Implant, Dental, Endosseous | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[08809985664922]
Moist Heat or Steam Sterilization
[08809985664922]
Moist Heat or Steam Sterilization
[08809985664922]
Moist Heat or Steam Sterilization
[08809985664922]
Moist Heat or Steam Sterilization
[08809985664922]
Moist Heat or Steam Sterilization
[08809985664922]
Moist Heat or Steam Sterilization
[08809985664922]
Moist Heat or Steam Sterilization
[08809985664922]
Moist Heat or Steam Sterilization
[08809985664922]
Moist Heat or Steam Sterilization
[08809985664922]
Moist Heat or Steam Sterilization
[08809985664922]
Moist Heat or Steam Sterilization
[08809985664922]
Moist Heat or Steam Sterilization
[08809985664922]
Moist Heat or Steam Sterilization
[08809985664922]
Moist Heat or Steam Sterilization
[08809985664922]
Moist Heat or Steam Sterilization
[08809985664922]
Moist Heat or Steam Sterilization
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2024-12-09 | 
| Device Publish Date | 2024-11-29 | 
| 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 |