AUTO REF/KERATOMETER

GUDID 04987669100745

The NIDEK AUTO REF/KERATOMETER ARK-1s measures spherical, cylindrical refractive errors, and cylinder axis from the refractive status of the patient’s eye. In addition, subjective test is performed with the built-in charts and lenses for subjective measurement. The keratometer measures the corneal curvature radius (corneal refractive power), principal meridian directions, and corneal cylindrical power.

NIDEK CO.,LTD.

Ophthalmic refractometer, automated

• Primary Device ID: 04987669100745
• NIH Device Record Key: cf3d6109-e873-429f-ba49-75c29be99cd9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AUTO REF/KERATOMETER
• Version Model Number: ARK-1s
• Company DUNS: 690635461
• Company Name: NIDEK CO.,LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

Customer Support Contacts

• Phone: 1-800-223-9044
• Email: info@nidek.com
• Phone: 1-800-223-9044
• Email: info@nidek.com
• Phone: 1-800-223-9044
• Email: info@nidek.com
• Phone: 1-800-223-9044
• Email: info@nidek.com
• Phone: 1-800-223-9044
• Email: info@nidek.com
• Phone: 1-800-223-9044
• Email: info@nidek.com
• Phone: 1-800-223-9044
• Email: info@nidek.com
• Phone: 1-800-223-9044
• Email: info@nidek.com
• Phone: 1-800-223-9044
• Email: info@nidek.com
• Phone: 1-800-223-9044
• Email: info@nidek.com
• Phone: 1-800-223-9044
• Email: info@nidek.com
• Phone: 1-800-223-9044
• Email: info@nidek.com
• Phone: 1-800-223-9044
• Email: info@nidek.com
• Phone: 1-800-223-9044
• Email: info@nidek.com
• Phone: 1-800-223-9044
• Email: info@nidek.com
• Phone: 1-800-223-9044
• Email: info@nidek.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04987669100745 [Primary]

FDA Product Code

• HKO: Refractometer, Ophthalmic

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: 2020-03-05
• Device Publish Date: 2018-04-20

On-Brand Devices [AUTO REF/KERATOMETER]

• 04987669101476: The AUTO REF/KERATOMETER ARK-F is a medical device which measures objective refractive errors an
• 04987669100745: The NIDEK AUTO REF/KERATOMETER ARK-1s measures spherical, cylindrical refractive errors, and cyl
• 04987669100738: The NIDEK AUTO REF/KERATOMETER ARK-1s measures spherical, cylindrical refractive errors, and cyl
• 04987669100721: The NIDEK AUTO REF/KERATOMETER ARK-1a/ARK-1 measures spherical, cylindrical refractive errors, a
• 04987669100714: The NIDEK AUTO REF/KERATOMETER ARK-1a/ARK-1 measures spherical, cylindrical refractive errors, a