| Primary Device ID | 08800197900075 |
| NIH Device Record Key | ca2deed9-b059-42ca-981b-5f1b5868e127 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ATOZ Expander Kit |
| Version Model Number | ATOZ Expander Kit*10SET |
| Company DUNS | 695009476 |
| Company Name | MK Meditech Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 | 08800197900075 [Primary] |
| DYJ | Retainer, Screw Expansion, Orthodontic |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08800197900075]
Moist Heat or Steam Sterilization
[08800197900075]
Moist Heat or Steam Sterilization
[08800197900075]
Moist Heat or Steam Sterilization
[08800197900075]
Moist Heat or Steam Sterilization
[08800197900075]
Moist Heat or Steam Sterilization
[08800197900075]
Moist Heat or Steam Sterilization
[08800197900075]
Moist Heat or Steam Sterilization
[08800197900075]
Moist Heat or Steam Sterilization
[08800197900075]
Moist Heat or Steam Sterilization
[08800197900075]
Moist Heat or Steam Sterilization
[08800197900075]
Moist Heat or Steam Sterilization
[08800197900075]
Moist Heat or Steam Sterilization
[08800197900075]
Moist Heat or Steam Sterilization
[08800197900075]
Moist Heat or Steam Sterilization
[08800197900075]
Moist Heat or Steam Sterilization
[08800197900075]
Moist Heat or Steam Sterilization
[08800197900075]
Moist Heat or Steam Sterilization
[08800197900075]
Moist Heat or Steam Sterilization
[08800197900075]
Moist Heat or Steam Sterilization
[08800197900075]
Moist Heat or Steam Sterilization
[08800197900075]
Moist Heat or Steam Sterilization
[08800197900075]
Moist Heat or Steam Sterilization
[08800197900075]
Moist Heat or Steam Sterilization
[08800197900075]
Moist Heat or Steam Sterilization
[08800197900075]
Moist Heat or Steam Sterilization
[08800197900075]
Moist Heat or Steam Sterilization
[08800197900075]
Moist Heat or Steam Sterilization
[08800197900075]
Moist Heat or Steam Sterilization
[08800197900075]
Moist Heat or Steam Sterilization
[08800197900075]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-01-31 |
| Device Publish Date | 2022-01-22 |
| 08800197900075 | ATOZ Expander Kit *10SET |
| 08800197900068 | The ATOZ Expander Kit is a procedure kit used for orthodontic treatment and consists of an expan |
| 08800197900341 | The ATOZ Expander Kit is a procedure kit used for orthodontic treatment and consists of an expan |