FDA UDI
In Commercial Distribution
🇺🇸 United States
AMA Optics Polarizing Glasses
DI: G506PG010
·
Model: PG-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 Polarizing Glasses
- Primary DI
- G506PG010
- Version / Model
- PG-01
- Catalog Number
- PG01
- 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
- 8242ee6d-b136-4579-b0c2-2617619ede52
Device Description
Glasses that change the plane of polarization when linearly polarized light traverses an optically active solid or liquid. This device may also be used in ophthalmology.
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 |
|---|---|---|---|---|
| HQG | Lens, Spectacle, Non-Custom (Prescription) | Ophthalmic | 886.5844 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36452 | Polarimeter | A mains electricity (AC-powered) instrument that measures the change in the plane of polarization when linearly polarized light traverses an optically active solid or liquid. This device may also be used in ophthalmology. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | G506PG010 | HIBCC |