FDA UDI
In Commercial Distribution
🇺🇸 United States
AMA Optics Amblyometer
DI: G506AMBYO010
·
Model: Amblyo-01
·
AMA Optics, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- AMA Optics Amblyometer
- Primary DI
- G506AMBYO010
- Version / Model
- Amblyo-01
- Catalog Number
- AMBLYO01
- Company Name
- AMA Optics, Inc.
- Labeler DUNS
- 192827462
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-01
- Public Version
- 1
- Public Version Date
- 2023-08-09
- Public Version Status
- New
- Public Device Record Key
- 657a2ae9-4b7d-4e71-a61b-d6a1d20ed705
Device Description
An ophthalmic device for binocular vision testing. The patient views a two image pairs stacked (Top = right dim image/left bright image; Bottom = right bright image//left dim image) through polarizing glasses of a polarizing system and informs the examining doctor when the combination perceived changes. This visual impression provides the information whereby a diagnosis of unconscious suppression of one eye can be determined.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HLC | Instrument, Measuring, Stereopsis | Ophthalmic | 886.1460 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37071 | Binocular vision test unit | An ophthalmic device for binocular vision testing. The patient views a four-dot light combination (1 white, 1 red and 2 green) through coloured glasses and informs the examining doctor when the combination perceived changes. This visual impression provides the information whereby a diagnosis of unconscious suppression of one eye can be determined. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | G506AMBYO010 | HIBCC |