| Primary Device ID | 04571130283350 |
| NIH Device Record Key | f3b3b1c0-02e5-440e-86fd-09a88a3a824e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AUTO KERATO-REFRACTOMETER KR-800 |
| Version Model Number | KR-800 |
| Company DUNS | 690542881 |
| Company Name | TOPCON CORPORATION |
| 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 | 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 | 04571130283350 [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 | 2024-05-17 |
| Device Publish Date | 2024-05-09 |
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| 04571130283350 - AUTO KERATO-REFRACTOMETER KR-800 | 2024-05-17 |
| 04571130283350 - AUTO KERATO-REFRACTOMETER KR-800 | 2024-05-17 |