FDA.reportPublic FDA data

AdaptDx Pro Eye Cups

Primary DI
00850006785049
Brand
AdaptDx Pro Eye Cups
Company
MACULOGIX, INC.
Model
10319
Device description
Left and right eye cups for the AdaptDx Pro headset.
Published
2021-04-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HJWAdaptometer (Biophotometer)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HJWAdaptometer (Biophotometer)Ophthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850006785046PackageGS11In Commercial Distribution
00850006785049PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085000678504610850006785046
00850006785049008500067850498500067850490850006785049

GMDN Terms#

Term, Definition table
TermDefinition
AdaptometerA mains electricity (AC-powered) ophthalmic device that provides a stimulating light source having various controlled intensities intended to measure the time required for retinal adaptation (regeneration of the visual purple) and the minimum light threshold.

Regulatory Flags#

DUNS number
962692179
Device count
1
Premarket exempt
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850006785070AdaptDx Pro USB-C Headset Cable103882022-01-27
00850006785087AdaptDx Pro USB-C Wall Charger103892022-01-27
00850006785001AdaptDxDx-042022-01-27
10850006785077AdaptDx Pro USB-C Headset Cable103882022-01-27
10850006785084AdaptDx Pro USB-C Wall Charger103892022-01-27
00850006785100AdaptDx Pro International103902022-01-27
00850006785025AdaptDx Pro USB-C Wall Charger International108702022-01-26
00850006785018AdapDx ProM-12021-04-09
00850006785032AdaptDx Pro Handheld ControllerHC-12021-04-09
00850006785056AdaptDx Pro Head Strap liner101452021-04-09
00850006785063AdaptDx Pro Head StrapHS-12021-04-09
10850006785039AdaptDx Pro Handheld ControllerHC-12021-04-09
10850006785015AdapDx ProM-12021-04-09
10850006785053AdaptDx Pro Head Strap liner101452021-04-09
10850006785060AdaptDx Pro Head StrapHS-12021-04-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810056991302aprevoCarlsmed, Inc.HJW2023-01-09
10850006785015AdapDx ProMACULOGIX, INC.HJW2021-04-09
10850006785053AdaptDx Pro Head Strap linerMACULOGIX, INC.HJW2021-04-09
10850006785060AdaptDx Pro Head StrapMACULOGIX, INC.HJW2021-04-09