| Primary Device ID | 08809358430291 |
| NIH Device Record Key | 85525365-eb8d-45a7-81d7-2e70969c8660 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Medizs Auto Refractometer-Keratometer |
| Version Model Number | RK-11 |
| Catalog Number | RK-11 |
| Company DUNS | 557804864 |
| Company Name | MEDIZS 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 | false |
| Lot Batch | false |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08809358430291 [Primary] |
| HKO | Refractometer, Ophthalmic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-03-31 |
| Device Publish Date | 2021-03-23 |
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| 08809358430291 - Medizs Auto Refractometer-Keratometer | 2021-03-31 Medizs Auto Refractometer-Keratometer RK-11 is a refraction device to measure Both of Refractometry & Keratometry. And also, it |
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