AMA Optics Occluder

Primary DI
G506OCCLM0
Brand
AMA Optics Occluder
Company
AMA Optics, Inc.
Model
O-MAGNETIC
Catalog number
OCCLM
Device description
A hand-operated, non-powered ophthalmic device intended to temporarily prevent and/or attenuate the passage of light (vision) to the eye(s) during an eyesight examination (e.g., diagnosis/measurement of heterophoria/heterotropia, myopia). The part of the device used to cover the eye(s) is typically spoon- or oval-shaped, and may be fully opaque or incorporate small holes and/or a Maddox lens(es) [i.e., coloured lens(es)]; the device also incorporates a handle and/or binocular frame. This is a reusable device.
Published
2023-08-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G506OCCLM0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Ocular occluder/Maddox rodA hand-operated, non-powered ophthalmic device intended to temporarily prevent and/or attenuate the passage of light (vision) to the eye(s) during an eyesight examination (e.g., diagnosis/measurement of heterophoria/heterotropia, myopia). The part of the device used to cover the eye(s) is typically spoon- or oval-shaped, and may be fully opaque or incorporate small holes and/or a Maddox lens(es) [i.e., coloured lens(es)]; the device also incorporates a handle and/or binocular frame. This is a reusable device.

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
G506PH010AMA Optics Panoramic PinholePH-01-PHPH012023-09-01
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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B945TLRSM1000BernellBernellHPC2026-05-03
B945TLRSM10000BernellBernellHPC2026-05-03
B945TLRSM10500BernellBernellHPC2026-05-03
B945TLRSM11000BernellBernellHPC2026-05-03
B945TLRSM12000BernellBernellHPC2026-05-03
B945TLRSM1250BernellBernellHPC2026-05-03
B945TLRSM13000BernellBernellHPC2026-05-03
B945TLRSM14000BernellBernellHPC2026-05-03
B945TLRSM1500BernellBernellHPC2026-05-03
B945TLRSM15000BernellBernellHPC2026-05-03
B945TLRSM16000BernellBernellHPC2026-05-03
B945TLRSM1750BernellBernellHPC2026-05-03
B945TLRSM18000BernellBernellHPC2026-05-03
B945TLRSM2000BernellBernellHPC2026-05-03
B945TLRSM20000BernellBernellHPC2026-05-03
B945TLRSM2250BernellBernellHPC2026-05-03
B945TLRSM2500BernellBernellHPC2026-05-03
B945TLRSM2750BernellBernellHPC2026-05-03
B945TLRSM3000BernellBernellHPC2026-05-03
B945TLRSM3250BernellBernellHPC2026-05-03
B945TLRSM3500BernellBernellHPC2026-05-03
B945TLRSM3750BernellBernellHPC2026-05-03
B945TLRSM4000BernellBernellHPC2026-05-03
B945TLRSM4250BernellBernellHPC2026-05-03
B945TLRSM4500BernellBernellHPC2026-05-03
B945TLRSM4750BernellBernellHPC2026-05-03
B945TLRSM5000BernellBernellHPC2026-05-03
B945TLRSM5250BernellBernellHPC2026-05-03