FDA.reportPublic FDA data

AMA Optics Panoramic Pinhole

Primary DI
G506PH010
Brand
AMA Optics Panoramic Pinhole
Company
AMA Optics, Inc.
Model
PH-01-PH
Catalog number
PH01
Device description
An individual ophthalmic lens from a trial lens set having multiple pinholes separate by clear plastic.
Published
2023-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HPBClip, Lens, Trial, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HPBClip, Lens, Trial, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G506PH010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Trial lensAn individual ophthalmic lens from a trial lens set.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
192827462
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G506DG010AMA Optics Digital Vision TestDiagnosticGameDG012023-08-01
G506HOLDER010AMA Optics Lens HolderLH-01HOLDER012023-08-01
G506LY010AMA Optics LanyardLY-01LY012023-08-01
G506RAM01160AMA Optics CordCACL-CORDRAM01162023-08-01
G506RAM0280 AMA Optics CordCALC-CORDRAM0282023-08-01
G506RAM03160AMA Optics CordCALC-CORDRAM03162023-08-01
G506NC010NeuroColorCOLOR-01NC012023-09-30
G506BAM010AMA Optics Brightness Acuity MeterGLARE-01-DEUCEBAM012023-09-01
G506MACDX010MacDxMACDX-01-PROMACDX012023-09-01
G506PHLC010AMA Optics Pinhole ClipPHC-01-PHPHLC012023-09-01
G506PHLC020RAM Panoramic Pinhole ClipPHC-O1-PPHPHL022023-09-01
G506RAM030AMA Optics RetinometerRAM-03-PRAM032023-09-01
G506RAM040AMA Optics RetinometerRAM-04-PXLRAM042023-09-01
G506RAM050AMA Optics ETDRSRAM ETDRSRAM052023-09-01
G506RAM20AMA Optics RetinometerRAM-01-ORAM022023-09-01
G506FRAME010RAM Testing FramesFrames-01FRAME012023-08-01
G506AMBYO010AMA Optics AmblyometerAmblyo-01AMBLYO012023-08-01
G506CCCLC0AMA Optics OccluderO-CLIPOCCLC2023-08-01
G506LVA010AMA Optics Vision AdaptorLVA-01LVA012023-08-01
G506OCCLM0AMA Optics OccluderO-MAGNETICOCCLM2023-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B945BC12701000BernellBernellHPB2026-05-03
B945BC1270100NI0BernellBernellHPB2026-05-03
B945BC12701250BernellBernellHPB2026-05-03
B945BC1270125NI0BernellBernellHPB2026-05-03
B945BC12701500BernellBernellHPB2026-05-03
B945BC1270150NI0BernellBernellHPB2026-05-03
B945BC12701750BernellBernellHPB2026-05-03
B945BC1270175NI0BernellBernellHPB2026-05-03
B945BC12702000BernellBernellHPB2026-05-03
B945BC1270200NI0BernellBernellHPB2026-05-03
B945BC12702250BernellBernellHPB2026-05-03
B945BC1270225NI0BernellBernellHPB2026-05-03
B945BC1270250BernellBernellHPB2026-05-03
B945BC12702500BernellBernellHPB2026-05-03
B945BC1270250NI0BernellBernellHPB2026-05-03
B945BC127025500BernellBernellHPB2026-05-03
B945BC12702550NI0BernellBernellHPB2026-05-03
B945BC127025NI0BernellBernellHPB2026-05-03
B945BC12702750BernellBernellHPB2026-05-03
B945BC1270275NI0BernellBernellHPB2026-05-03
B945BC12703000BernellBernellHPB2026-05-03
B945BC1270300NI0BernellBernellHPB2026-05-03
B945BC12703250BernellBernellHPB2026-05-03
B945BC1270325NI0BernellBernellHPB2026-05-03
B945BC12703500BernellBernellHPB2026-05-03
B945BC1270350NI0BernellBernellHPB2026-05-03
B945BC12703750BernellBernellHPB2026-05-03
B945BC1270375NI0BernellBernellHPB2026-05-03
B945BC12704000BernellBernellHPB2026-05-03
B945BC1270400NI0BernellBernellHPB2026-05-03