KOWA VK-2s

GUDID 04987646808947

KOWA VK-2s is indicated for acquiring, displaying and storing image data from KOWA's mydriatic and non-mydriatic ophthalmic cameras.

KOWA COMPANY,LTD.

Medical image management system

• Primary Device ID: 04987646808947
• NIH Device Record Key: 4395b7d2-ad69-4806-9564-c710cce0f4e0
• Commercial Distribution Discontinuation: 2019-06-10
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: KOWA VK-2s
• Version Model Number: VK28U2E
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	04987646808947 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190056

FDA Product Code

• NFJ: System, Image Management, Ophthalmic

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: 2019-06-18
• Device Publish Date: 2019-06-10

On-Brand Devices [KOWA VK-2s]

• 04987646808947: KOWA VK-2s is indicated for acquiring, displaying and storing image data from KOWA's mydriatic a
• 04987646808930: KOWA VK-2s is indicated for acquiring, displaying and storing image data from KOWA's mydriatic a
• 04987646808923: KOWA VK-2s is indicated for acquiring, displaying and storing image data from KOWA's mydriatic a