| Primary Device ID | 08806388270378 |
| NIH Device Record Key | ef417a04-1f25-4560-b826-7b396faf70f2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Implant Carrier |
| Version Model Number | ICWT50RT |
| 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 | 08806388270378 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08806388270378]
Moist Heat or Steam Sterilization
[08806388270378]
Moist Heat or Steam Sterilization
[08806388270378]
Moist Heat or Steam Sterilization
[08806388270378]
Moist Heat or Steam Sterilization
[08806388270378]
Moist Heat or Steam Sterilization
[08806388270378]
Moist Heat or Steam Sterilization
[08806388270378]
Moist Heat or Steam Sterilization
[08806388270378]
Moist Heat or Steam Sterilization
[08806388270378]
Moist Heat or Steam Sterilization
[08806388270378]
Moist Heat or Steam Sterilization
[08806388270378]
Moist Heat or Steam Sterilization
[08806388270378]
Moist Heat or Steam Sterilization
[08806388270378]
Moist Heat or Steam Sterilization
[08806388270378]
Moist Heat or Steam Sterilization
[08806388270378]
Moist Heat or Steam Sterilization
[08806388270378]
Moist Heat or Steam Sterilization
[08806388270378]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-02-10 |
| Device Publish Date | 2025-01-31 |
| 08806388267217 | Octa 2.1/ Regular |
| 08806388267200 | Octa 2.5/ Regular |
| 08806388220380 | ST Regular/ Hex2.1 |
| 08806388220373 | Common Narrow/ Hex1.7 |
| 08809728993845 | R2 Octa 2.5/ Regular |
| 08809728993838 | R2 Octa 2.1/ Regular |
| 08809854020002 | Common Narrow/ Hex2.3 |
| 08809931181534 | ICWO2530 |
| 08809931181527 | ICWO2530H |
| 08806388262526 | ICWH2711CT |
| 08806388262519 | ICRH2221CT |
| 08806388262502 | ICWH2538OS |
| 08806388262496 | ICRH2127OS |
| 08806388270422 | ICWT43RT |
| 08806388270378 | ICWT50RT |
| 08806388270361 | ICRT35RT |
| 08806388262489 | ICWH2624 |
| 08806388246489 | ICRSBLH |
| 08806388246472 | ICRSBNH |
| 08806388246465 | ICRSBL2 |
| 08806388246458 | ICRSBN |
| 08806388244522 | ICRH2523O |
| 08806388244515 | ICRH2523HO |