KOWA DR-1α

GUDID 04987646807728

The KOWA DR-1α is an ocular surface interferometer, which is an ophthalmic imaging device that is intended for use by physician in adult patients to observe and record a video image of specular (interferometric) observations of the tear film, which can be visually monitored and photographically documented.

KOWA COMPANY,LTD.

Ophthalmic fundus camera

• Primary Device ID: 04987646807728
• NIH Device Record Key: 5cbf99cc-65a9-4e57-a9e9-448e178db7ad
• Commercial Distribution Discontinuation: 2019-06-10
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: KOWA DR-1α
• Version Model Number: DE2K
• 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

Operating and Storage Conditions

• Handling Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04987646807728 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190573

FDA Product Code

• HKI: Camera, Ophthalmic, 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: 2019-06-18
• Device Publish Date: 2019-06-10

Devices Manufactured by KOWA COMPANY,LTD.

• 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: 2019-06-18The KOWA DR-1α is an ocular surface interferometer, which is an ophthalmic imaging device that is intended for use by physician in adult patients to observe and record a video image of specular (interferometric) observations of the tear film, which can be visually monitored and photographically documented.
• 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
• 04987646808923 - KOWA VK-2s: 2019-06-18 KOWA VK-2s is indicated for acquiring, displaying and storing image data from KOWA's mydriatic and non-mydriatic ophthalmic came