NeuroColor NC01

GUDID G506NC010

An ophthalmic device that consists of various coloured materials, e.g., coloured yarns or colour vision plates (multicoloured plates which patients with colour vision deficiency would perceive as being of one colour), used for evaluating colour vision.

AMA Optics, Inc.

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• Primary Device ID: G506NC010
• NIH Device Record Key: 3c831810-e6fe-43d9-9348-3d601b1ae38f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeuroColor
• Version Model Number: COLOR-01
• Catalog Number: NC01
• Company DUNS: 192827462
• Company Name: AMA Optics, Inc.
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	G506NC010 [Primary]

FDA Product Code

• HIT: Tester, Color Vision

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: 2023-10-09
• Device Publish Date: 2023-09-30

Devices Manufactured by AMA Optics, Inc.

• G506NC010 - NeuroColor: 2023-10-09An ophthalmic device that consists of various coloured materials, e.g., coloured yarns or colour vision plates (multicoloured plates which patients with colour vision deficiency would perceive as being of one colour), used for evaluating colour vision.
• G506NC010 - NeuroColor: 2023-10-09 An ophthalmic device that consists of various coloured materials, e.g., coloured yarns or colour vision plates (multicoloured pl
• G506BAM010 - AMA Optics Brightness Acuity Meter: 2023-09-11 A hand-held device that illuminates the eye while viewing a visual acuity chart for measuring the presence and degree of glare.
• G506MACDX010 - MacDx: 2023-09-11 MacDx Dark Adaptometer is a device to measure dark adaptation of the retina.
• G506PH010 - AMA Optics Panoramic Pinhole: 2023-09-11 An individual ophthalmic lens from a trial lens set having multiple pinholes separate by clear plastic.
• G506PHLC010 - AMA Optics Pinhole Clip: 2023-09-11 A lens chip having an optical lens and a pinhole disc with multiple apertures.
• G506PHLC020 - RAM Panoramic Pinhole Clip: 2023-09-11 A lens clip having an optical lens and a pinhole disc with multiple apertures, each surrounded by an opaque halo.
• G506RAM030 - AMA Optics Retinometer: 2023-09-11 An ophthalmic retro-illuminated chart with adjustable brightness that is printed with various symbols (letters, numbers, picture
• G506RAM040 - AMA Optics Retinometer: 2023-09-11 An ophthalmic retro-illuminated chart with adjustable brightness that is printed with various symbols (letters, numbers, picture