Primary Device ID | 04987646810063 |
NIH Device Record Key | b4720ecc-d4ca-4157-b304-e9c9e6066c17 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | KOWA SL-19 |
Version Model Number | SL191K/P |
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 |
Width | 107 Millimeter |
Depth | 197 Millimeter |
Height | 238 Millimeter |
Weight | 620 Gram |
Width | 107 Millimeter |
Depth | 197 Millimeter |
Height | 238 Millimeter |
Weight | 620 Gram |
Width | 107 Millimeter |
Depth | 197 Millimeter |
Height | 238 Millimeter |
Weight | 620 Gram |
Width | 107 Millimeter |
Depth | 197 Millimeter |
Height | 238 Millimeter |
Weight | 620 Gram |
Storage Environment Temperature | Between -10 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 35 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -10 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 35 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -10 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 35 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -10 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 35 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Device Issuing Agency | Device ID |
---|---|
GS1 | 04987646810063 [Primary] |
HJO | Biomicroscope, Slit-Lamp, Ac-Powered |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-12-15 |
Device Publish Date | 2022-12-07 |
04987646810070 | KOWA SL-19 is intended for use in eye examination of the anterior eye segment, from the cornea e |
04987646810063 | KOWA SL-19 is intended for use in eye examination of the anterior eye segment, from the cornea e |
04987646810056 | KOWA SL-19 is intended for use in eye examination of the anterior eye segment, from the cornea e |
04987646810049 | KOWA SL-19 is intended for use in eye examination of the anterior eye segment, from the cornea e |
04987646810032 | KOWA SL-19 is intended for use in eye examination of the anterior eye segment, from the cornea e |