KOWA SL-19

GUDID 04987646810049

KOWA SL-19 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 in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment.

KOWA COMPANY,LTD.

Ophthalmic slit lamp, examination Ophthalmic slit lamp, examination Ophthalmic slit lamp, examination Ophthalmic slit lamp, examination

• Primary Device ID: 04987646810049
• NIH Device Record Key: b151bec8-af90-44c8-8528-1d032b0fb256
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KOWA SL-19
• Version Model Number: SL191K/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

• 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
• Width: 107 Millimeter
• Depth: 197 Millimeter
• Height: 238 Millimeter

Operating and Storage Conditions

• 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 Identifiers

Device Issuing Agency	Device ID
GS1	04987646810049 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222372

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-15
• Device Publish Date: 2022-12-07

On-Brand Devices [KOWA SL-19]

• 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