AccessGUDID - DEVICE: AMA Optics Eye Chart (G506VAL010)

GUDID

Device Identifier (DI) Information

Brand Name: AMA Optics Eye Chart
Version or Model: EC-L-01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: VAL01
Company Name: AMA Optics, Inc.

Primary DI Number: G506VAL010
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 192827462 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HOX	Chart, Visual Acuity

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f0c603e8-495e-471f-87ff-8f63d197fa6f
Public Version Date: August 09, 2023
Public Version Number: 1
DI Record Publish Date: August 01, 2023