| Primary Device ID | 08800197900556 |
| NIH Device Record Key | 0337b22b-841c-4492-b5dc-258f1f06d6c8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ATOZ Screwdriver |
| Version Model Number | MKD-S |
| Company DUNS | 695009476 |
| Company Name | MK Meditech Inc. |
| 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 | 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 | 08800197900556 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08800197900556]
Moist Heat or Steam Sterilization
[08800197900556]
Moist Heat or Steam Sterilization
[08800197900556]
Moist Heat or Steam Sterilization
[08800197900556]
Moist Heat or Steam Sterilization
[08800197900556]
Moist Heat or Steam Sterilization
[08800197900556]
Moist Heat or Steam Sterilization
[08800197900556]
Moist Heat or Steam Sterilization
[08800197900556]
Moist Heat or Steam Sterilization
[08800197900556]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-12-31 |
| Device Publish Date | 2024-12-23 |
| 08800197900051 | PRODUCT SUMMARY This is used for insertion and removal of the ATOZ Mini-screw. The driver is des |
| 08800197900563 | PRODUCT SUMMARY This is used for insertion and removal of the ATOZ Mini-screw. The driver is des |
| 08800197900556 | PRODUCT SUMMARY This is used for insertion and removal of the ATOZ Mini-screw. The driver is des |