3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-2000

GUDID 04562123288261

TOPCON CORPORATION

Retinal optical coherence tomography system

• Primary Device ID: 04562123288261
• NIH Device Record Key: 086e6a4c-5189-4f0d-8840-05b7893c3df5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-2000
• Version Model Number: 3D OCT-2000
• 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	04562123288261 [Primary]

FDA Product Code

• OBO: Tomography, optical coherence

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-19

Devices Manufactured by TOPCON CORPORATION

• 04560126268495 - SightPilot NAVi Contoller SNi-1 for COMPU VISION CV-5000: 2025-03-07
• 04560126268532 - COMPU VISION CV-5000: 2025-03-07
• 04560126268549 - COMPU VISION CV-5000: 2025-03-07
• 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