AMA Optics Retinometer RAM01

GUDID G506RAM010

An ophthalmic retro-illuminated chart printed with various symbols (letters, numbers, pictures, dots) intended to be used for testing visual acuity (e.g., Snellen chart) for routine visual function examination (e.g., preoperative visual acuity prediction and postoperative visual acuity recovery assessment for cataract, glaucoma, retinopathy, amblyopia, etc.). The chart is exchangeable.

AMA Optics, Inc.

Vision testing/training chart

• Primary Device ID: G506RAM010
• NIH Device Record Key: 04c87ddf-b889-4e20-8156-4401ce90f413
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMA Optics Retinometer
• Version Model Number: RAM-01-M
• Catalog Number: RAM01
• 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	G506RAM010 [Primary]

FDA Product Code

• HOX: Chart, Visual Acuity

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 Retinometer]

• G506RAM010: An ophthalmic retro-illuminated chart printed with various symbols (letters, numbers, pictures,
• G506RAM20: An ophthalmic retro-illuminated chart printed with various symbols (letters, numbers, pictures,
• G506RAM040: An ophthalmic retro-illuminated chart with adjustable brightness that is printed with various sy
• G506RAM030: An ophthalmic retro-illuminated chart with adjustable brightness that is printed with various sy