| Primary Device ID | 00850724001322 |
| NIH Device Record Key | 20c66837-d007-43ac-bdcc-6cca8f63bcde |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ML7030 (Minus 20) |
| Version Model Number | ML7030 (-20) |
| Catalog Number | ML7030 (-20) |
| Company DUNS | 075390489 |
| Company Name | MED LOGICS INC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | true |
| 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 | 00850724001322 [Primary] |
| GS1 | 10850724001329 [Package] Package: Box [10 Units] In Commercial Distribution |
| HNO | Keratome, Ac-Powered |
| KYG | Device, Irrigation, Ocular Surgery |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00850724001322]
Ethylene Oxide
[00850724001322]
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| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-07-29 |
| Device Publish Date | 2020-07-21 |
| 10850724001107 - Vacuum Tubing | 2020-09-07 Disposable Microkeratome Vacuum Tubing |
| 00850724001902 - ML7 Eye Marker | 2020-09-07 Eye Marker use to mark the cornea to orientate the ML7 Vacuum Ring |
| 00850011743997 - Wrench, Helical Drive, ML7 | 2020-09-04 Wrench use to adjust helical screw on the ML7 Vacuum Rings |
| 10850724001206 - Vacuum Tubing | 2020-09-04 Disposable Tubing for use with the ML7 Microkeratome |
| 00850724001681 - ML7 Microkeratome | 2020-09-04 Console for use with the ML7 microkeratome |
| 00850724001780 - Footswitch, ML7 | 2020-09-04 Footswitch for use with the ML7 microkeratome |
| 00850724001803 - Handpiece, ML7 | 2020-09-04 Handpiece for use with the ML7 Microkeratome |
| 00850724001810 - Sterilization Tray, ML7 | 2020-09-04 Sterilization tray for use with the ML7 microkeratome |