| Primary Device ID | 08800293008187 |
| NIH Device Record Key | 5059d04f-9690-46a9-8e59-2b7304f946d0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PET Kit |
| Version Model Number | MKPET3000M |
| Catalog Number | MKPET3000M |
| 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 | 08800293008187 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08800293008187]
Moist Heat or Steam Sterilization
[08800293008187]
Moist Heat or Steam Sterilization
[08800293008187]
Moist Heat or Steam Sterilization
[08800293008187]
Moist Heat or Steam Sterilization
[08800293008187]
Moist Heat or Steam Sterilization
[08800293008187]
Moist Heat or Steam Sterilization
[08800293008187]
Moist Heat or Steam Sterilization
[08800293008187]
Moist Heat or Steam Sterilization
[08800293008187]
Moist Heat or Steam Sterilization
[08800293008187]
Moist Heat or Steam Sterilization
[08800293008187]
Moist Heat or Steam Sterilization
[08800293008187]
Moist Heat or Steam Sterilization
[08800293008187]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-07-09 |
| Device Publish Date | 2025-07-01 |
| 08806388286072 | PET3000 |
| 08800293008187 | Middle Kit |