3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(Type:Maestro2)

GUDID 04562123289251

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: 04562123289251
• NIH Device Record Key: 8f947c77-1c42-4e8e-a431-5ee79308f913
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(Type:Maestro2)
• 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	04562123289251 [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: 2019-07-10
• Device Publish Date: 2019-07-02

On-Brand Devices [3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(Type:Maestro2)]

• 04562123289251: 3D OCT-1
• 04571130282957: 3D OCT-1