3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1

GUDID 04562123288322

TOPCON CORPORATION

Retinal optical coherence tomography system Ophthalmic spectral-domain optical coherence tomography system Ophthalmic spectral-domain optical coherence tomography system Ophthalmic spectral-domain optical coherence tomography system Ophthalmic spectral-domain optical coherence tomography system Ophthalmic spectral-domain optical coherence tomography system Ophthalmic spectral-domain optical coherence tomography system Ophthalmic spectral-domain optical coherence tomography system Ophthalmic spectral-domain optical coherence tomography system Ophthalmic spectral-domain optical coherence tomography system Ophthalmic spectral-domain optical coherence tomography system Ophthalmic spectral-domain optical coherence tomography system Ophthalmic spectral-domain optical coherence tomography system Ophthalmic spectral-domain optical coherence tomography system Ophthalmic spectral-domain optical coherence tomography system Ophthalmic spectral-domain optical coherence tomography system Ophthalmic spectral-domain optical coherence tomography system

• Primary Device ID: 04562123288322
• NIH Device Record Key: 762e54f1-235b-4616-9c58-a22a83f5a223
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1
• Version Model Number: 3D OCT-1
• 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	04562123288322 [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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-19

On-Brand Devices [3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1]

• 04562123288605: 3D OCT-1
• 04562123288322: 3D OCT-1