AMA Optics Occluder OCCLM

GUDID G506OCCLM0

A hand-operated, non-powered ophthalmic device intended to temporarily prevent and/or attenuate the passage of light (vision) to the eye(s) during an eyesight examination (e.g., diagnosis/measurement of heterophoria/heterotropia, myopia). The part of the device used to cover the eye(s) is typically spoon- or oval-shaped, and may be fully opaque or incorporate small holes and/or a Maddox lens(es) [i.e., coloured lens(es)]; the device also incorporates a handle and/or binocular frame. This is a reusable device.

AMA Optics, Inc.

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• Primary Device ID: G506OCCLM0
• NIH Device Record Key: 63adffc2-1673-4d1a-a0be-888b5143025f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMA Optics Occluder
• Version Model Number: O-MAGNETIC
• Catalog Number: OCCLM
• 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	G506OCCLM0 [Primary]

FDA Product Code

• HPC: Set, Lens, Trial, Ophthalmic

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: 2023-08-09
• Device Publish Date: 2023-08-01

On-Brand Devices [AMA Optics Occluder]

• G506OCCLM0: A hand-operated, non-powered ophthalmic device intended to temporarily prevent and/or attenuate
• G506CCCLC0: A hand-operated, non-powered ophthalmic device intended to temporarily prevent and/or attenuate