DEVICE: AMA Optics Retinometer (G506RAM030)
Device Identifier (DI) Information
AMA Optics Retinometer
RAM-03-P
In Commercial Distribution
RAM03
AMA Optics, Inc.
RAM-03-P
In Commercial Distribution
RAM03
AMA Optics, Inc.
An ophthalmic retro-illuminated chart with adjustable brightness that is 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.).
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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16800 | Vision testing/training chart |
An ophthalmic chart or card printed with various symbols (e.g., letters, pictures or dots) intended to be used for testing visual acuity (e.g., Snellen chart) or testing and/or training accommodation and/or convergence or other amenable ophthalmic functions. The chart/card may be held in front of the patient or placed on a table or wall and may have specific user instructions depending on specific use. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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HOX | Chart, Visual Acuity |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
d1a1588d-5d72-4f15-97a8-b59e0c3e703f
September 11, 2023
1
September 01, 2023
September 11, 2023
1
September 01, 2023
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined