KOWA SL-17

GUDID 04987646806912

KOWA SL-17 is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid

KOWA COMPANY,LTD.

Ophthalmic slit lamp, examination

• Primary Device ID: 04987646806912
• NIH Device Record Key: 68bc43dd-e9be-4850-96d3-acde1013dc5a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KOWA SL-17
• Version Model Number: SL170K/A
• 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

Device Dimensions

• Height: 220 Millimeter
• Depth: 95 Millimeter
• Width: 220 Millimeter
• Weight: 745 Gram
• Height: 220 Millimeter
• Depth: 95 Millimeter
• Width: 220 Millimeter
• Weight: 745 Gram
• Height: 220 Millimeter
• Depth: 95 Millimeter
• Width: 220 Millimeter
• Weight: 745 Gram
• Height: 220 Millimeter
• Depth: 95 Millimeter
• Width: 220 Millimeter
• Weight: 745 Gram
• Height: 220 Millimeter
• Depth: 95 Millimeter
• Width: 220 Millimeter
• Weight: 745 Gram
• Height: 220 Millimeter
• Depth: 95 Millimeter
• Width: 220 Millimeter
• Weight: 745 Gram
• Height: 220 Millimeter
• Depth: 95 Millimeter
• Width: 220 Millimeter
• Weight: 745 Gram
• Height: 220 Millimeter
• Depth: 95 Millimeter
• Width: 220 Millimeter
• Weight: 745 Gram
• Height: 220 Millimeter
• Depth: 95 Millimeter
• Width: 220 Millimeter
• Weight: 745 Gram
• Height: 220 Millimeter
• Depth: 95 Millimeter
• Width: 220 Millimeter
• Weight: 745 Gram
• Height: 220 Millimeter
• Depth: 95 Millimeter
• Width: 220 Millimeter
• Weight: 745 Gram
• Height: 220 Millimeter
• Depth: 95 Millimeter
• Width: 220 Millimeter
• Weight: 745 Gram
• Height: 220 Millimeter
• Depth: 95 Millimeter
• Width: 220 Millimeter
• Weight: 745 Gram
• Height: 220 Millimeter
• Depth: 95 Millimeter
• Width: 220 Millimeter
• Weight: 745 Gram
• Height: 220 Millimeter
• Depth: 95 Millimeter
• Width: 220 Millimeter
• Weight: 745 Gram
• Height: 220 Millimeter
• Depth: 95 Millimeter
• Width: 220 Millimeter
• Weight: 745 Gram
• Height: 220 Millimeter
• Depth: 95 Millimeter
• Width: 220 Millimeter
• Weight: 745 Gram

Operating and Storage Conditions

• Storage 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 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage 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 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage 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 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage 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 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage 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 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage 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 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage 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 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage 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 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage 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 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage 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 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage 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 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage 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 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage 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 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage 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 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage 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 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage 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 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage 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 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	04987646806912 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133755

FDA Product Code

• HJO: Biomicroscope, Slit-Lamp, Ac-Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-16

On-Brand Devices [KOWA SL-17]

• 04987646806936: KOWA SL-17 is intended for use in eye examination of the anterior eye segment, from the cornea e
• 04987646806929: KOWA SL-17 is intended for use in eye examination of the anterior eye segment, from the cornea e
• 04987646806912: KOWA SL-17 is intended for use in eye examination of the anterior eye segment, from the cornea e
• 04987646806905: KOWA SL-17 is intended for use in eye examination of the anterior eye segment, from the cornea e