| Primary Device ID | 04987646800606 |
| NIH Device Record Key | 903a6991-7b9e-41ed-a21d-4edd2505845b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | KOWA nonmyd a-DIII |
| Version Model Number | K9L58K |
| Company DUNS | 692281073 |
| Company Name | KOWA COMPANY,LTD. |
| 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 | false |
| Lot Batch | false |
| Serial Number | true |
| 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 |
| Height | 462 Millimeter |
| Depth | 505 Millimeter |
| Width | 310 Millimeter |
| Weight | 22 Kilogram |
| Handling Environment Temperature | Between -15 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04987646800606 [Primary] |
| HKI | Camera, Ophthalmic, Ac-Powered |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2018-02-23 |
| 04987646810476 - KOWA SL-19 | 2024-10-16 The KOWA SL-19 is intended for use in animal's eye examination of the anterior eye segment, from the cornea epithelium to the po |
| 04987646810032 - KOWA SL-19 | 2022-12-15 KOWA SL-19 is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsu |
| 04987646810049 - KOWA SL-19 | 2022-12-15 KOWA SL-19 is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsu |
| 04987646810056 - KOWA SL-19 | 2022-12-15 KOWA SL-19 is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsu |
| 04987646810063 - KOWA SL-19 | 2022-12-15 KOWA SL-19 is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsu |
| 04987646810070 - KOWA SL-19 | 2022-12-15 KOWA SL-19 is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsu |
| 04987646809128 - KOWA nonmyd AF | 2020-01-23 KOWA nonmyd AF is intended for use with retinal image capturing without requiring the patients to take any mydriatic. |
| 04987646807728 - KOWA DR-1α | 2019-06-18 The KOWA DR-1α is an ocular surface interferometer, which is an ophthalmic imaging device that is intended for use by physician |