EXTERNAL FIXATION TARGET EF-2

GUDID 04562123289923

TOPCON CORPORATION

Ophthalmic fundus camera

• Primary Device ID: 04562123289923
• NIH Device Record Key: 6f11a54b-a65a-4bd5-b6f9-1809f0cf9772
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EXTERNAL FIXATION TARGET EF-2
• Version Model Number: EF-2
• Company DUNS: 690542881
• Company Name: TOPCON CORPORATION
• 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: 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	04562123289923 [Primary]

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: 2021-02-11
• Device Publish Date: 2021-02-03

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• 04560126268570 - 1DIAL CONTROLLER KB-50S: 2025-03-07
• 04560126268624 - POWER SUPPLY UNIT for CV-5000 (PC EXTERNAL TYPE): 2025-03-07
• 04560126268648 - POWER SUPPLY UNIT for CV-5000 (BUILT-IN PC TYPE): 2025-03-07
• 04571130282773 - REFRACTION SYSTEM Chronos: 2024-08-09
• 04571130283350 - AUTO KERATO-REFRACTOMETER KR-800: 2024-05-17