| Primary Device ID | 08809854028909 |
| NIH Device Record Key | 062ec179-16a0-49ec-be6e-052ff14330d9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Implant Mount Screw |
| Version Model Number | ARIEMS |
| Catalog Number | ARIEMS |
| 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 | 08809854028909 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08809854028909]
Moist Heat or Steam Sterilization
[08809854028909]
Moist Heat or Steam Sterilization
[08809854028909]
Moist Heat or Steam Sterilization
[08809854028909]
Moist Heat or Steam Sterilization
[08809854028909]
Moist Heat or Steam Sterilization
[08809854028909]
Moist Heat or Steam Sterilization
[08809854028909]
Moist Heat or Steam Sterilization
[08809854028909]
Moist Heat or Steam Sterilization
[08809854028909]
Moist Heat or Steam Sterilization
[08809854028909]
Moist Heat or Steam Sterilization
[08809854028909]
Moist Heat or Steam Sterilization
[08809854028909]
Moist Heat or Steam Sterilization
[08809854028909]
Moist Heat or Steam Sterilization
[08809854028909]
Moist Heat or Steam Sterilization
[08809854028909]
Moist Heat or Steam Sterilization
[08809854028909]
Moist Heat or Steam Sterilization
[08809854028909]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-02-28 |
| Device Publish Date | 2024-02-20 |
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| 08800292993460 - i-Peg | 2026-01-01 |
| 08800292993477 - i-Peg | 2026-01-01 |
| 08800292993484 - i-Peg | 2026-01-01 |
| 08800292993491 - i-Peg | 2026-01-01 |
| 08800292993507 - i-Peg | 2026-01-01 |
| 08800292999301 - i-Peg Mount | 2026-01-01 |
| 08800293009726 - R2i5 | 2025-12-11 |