3D OPTICAL COHERENCE TOMOGRAPHY DRI OCT Triton

GUDID 04562123289039

TOPCON CORPORATION

Retinal optical coherence tomography system

• Primary Device ID: 04562123289039
• NIH Device Record Key: b5856829-237d-4807-9e07-99572206b16b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3D OPTICAL COHERENCE TOMOGRAPHY DRI OCT Triton
• Version Model Number: DRI OCT Triton
• 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	04562123289039 [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-08-27
• Device Publish Date: 2018-02-07

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• 04560126268532 - COMPU VISION CV-5000: 2025-03-07
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