AUTO KERATO-REFRACTOMETER KR-800

GUDID 04571130283350

TOPCON CORPORATION

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• Primary Device ID: 04571130283350
• NIH Device Record Key: f3b3b1c0-02e5-440e-86fd-09a88a3a824e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AUTO KERATO-REFRACTOMETER KR-800
• Version Model Number: KR-800
• Company DUNS: 690542881
• Company Name: TOPCON CORPORATION
• 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: true
• 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	04571130283350 [Primary]

FDA Product Code

• HKO: Refractometer, 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: 2024-05-17
• Device Publish Date: 2024-05-09

Devices Manufactured by TOPCON CORPORATION

• 04571130283350 - AUTO KERATO-REFRACTOMETER KR-800: 2024-05-17
• 04571130283350 - AUTO KERATO-REFRACTOMETER KR-800: 2024-05-17
• 04571130283374 - AUTO REFRACTOMETER RM-800: 2024-05-17
• 04562123288384 - COMPUTERIZED LENSMETER CL-300: 2023-12-27
• 04562123288391 - COMPUTERIZED LENSMETER CL-300: 2023-12-27
• 04560126268198 - Chinrest CRX-1000 for REFRACTION SYSTEM Chronos: 2023-11-24
• 04560126264640 - INFRARED COMMUNICATION UNIT: 2022-09-08
• 04560126266071 - KR-1W Viewer: 2022-09-08
• 04562123280531 - PRISM COMPENSATOR for LENSMETER LM-8: 2022-09-08