FDA UDI
In Commercial Distribution
🇺🇸 United States
AMA Optics Lens Holder
DI: G506HOLDER010
·
Model: LH-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 Lens Holder
- Primary DI
- G506HOLDER010
- Version / Model
- LH-01
- Catalog Number
- HOLDER01
- 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
- 2
- Public Version Date
- 2025-11-20
- Public Version Status
- Update
- Public Device Record Key
- a317b258-e0b0-485f-bb04-4777d10c5550
Device Description
An individual ophthalmic lens from a trial lens set. (lens holder)
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 |
|---|---|---|---|---|
| HPC | Set, Lens, Trial, Ophthalmic | Ophthalmic | 886.1405 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34653 | Vision corrective trial lens | A non-patient-contact ophthalmic trial lens, or set of trial lenses of various dioptric powers, intended for vision testing to determine the required refraction for vision correction. This device may be used in conjunction with a phoropter (not included). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | G506HOLDER010 | HIBCC |