OCT500

GUDID 03615020000489

3D Optical Coherence Tomography OCT500 is a non-contact, high-resolution tomographic and biomicroscopic imaging device. It is indicated for in-vivo viewing, axial cross-sectional and three dimensional imaging, and measurement of posterior ocular structures, including the retina, retinal nerve fiber layer, ganglion cell plus inner plexiform layer, ganglion cell complex, macula, optic nerve head. It is also indicated for in-vivo viewing, axial cross-sectional and three dimensional imaging of anterior ocular structures, including the cornea. The instrument is intended for use as a diagnostic device to aid in the detection and management of ocular diseases including, but not limited to, macular holes, cystoid macular edema, diabetic retinopathy, agerelated macular degeneration, and glaucoma.

ESSILOR INTERNATIONAL

Retinal optical coherence tomography system

• Primary Device ID: 03615020000489
• NIH Device Record Key: d167f846-7e1e-4d99-ba2c-e1e858883177
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OCT500
• Version Model Number: OCT2JT
• Company DUNS: 277373213
• Company Name: ESSILOR INTERNATIONAL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

Customer Support Contacts

• Phone: +33172947322
• Email: qualite.instruments@essilor.fr

Operating and Storage Conditions

• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	03615020000489 [Primary]

FDA Product Code

• OBO: Tomography, Optical Coherence

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: 2020-03-31
• Device Publish Date: 2020-03-23

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