| Primary Device ID | 08809977450533 | 
| NIH Device Record Key | 94401f6e-8f8e-4558-af36-ffb193171dc0 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Impression Cylinder | 
| Version Model Number | AXIC406 | 
| Catalog Number | AXIC406T | 
| 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 | 08809977450533 [Primary] | 
| NDP | Accessories, Implant, Dental, Endosseous | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[08809977450533]
Moist Heat or Steam Sterilization
[08809977450533]
Moist Heat or Steam Sterilization
[08809977450533]
Moist Heat or Steam Sterilization
[08809977450533]
Moist Heat or Steam Sterilization
[08809977450533]
Moist Heat or Steam Sterilization
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2024-07-18 | 
| Device Publish Date | 2024-07-10 | 
| 08809985659386 | Common | 
| 08809985659379 | Common | 
| 08809985656767 | Common | 
| 08809985656750 | Common | 
| 08809985656743 | Common | 
| 08809977450557 | Common | 
| 08809977450540 | Common | 
| 08809977450533 | Common | 
| 08809977450526 | Common | 
| 08809985666094 | Ø5/ H=4 |