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
HPC Set, Lens, Trial, Ophthalmic

GMDN Terms

Code Name
34653 Vision corrective trial lens

Identifiers

Type ID
Primary G506HOLDER010