FDA.reportPublic FDA data

AdaptDx Pro Head Strap liner

Primary DI
10850006785053
Brand
AdaptDx Pro Head Strap liner
Company
MACULOGIX, INC.
Model
10145
Device description
Head strap liner for the AdaptDx Pro
Published
2021-04-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
HJWAdaptometer (Biophotometer)
OUMAdaptometer (Biophotometer), Software-Based Data Acquisition And Stimulus Generation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HJWAdaptometer (Biophotometer)Ophthalmic1
OUMAdaptometer (Biophotometer), Software-Based Data Acquisition And Stimulus GenerationOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850006785053PackageGS11In Commercial Distribution
00850006785056PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085000678505310850006785053
00850006785056008500067850568500067850560850006785056

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
962692179
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00850006785049AdaptDx Pro Eye Cups103192021-04-09
10850006785015AdapDx ProM-12021-04-09
10850006785060AdaptDx Pro Head StrapHS-12021-04-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860014752704TwilightEVOQ TECHNOLOGIES CORP.OUM2025-12-30
G506MACDX010MacDxAMA Optics, Inc.OUM2023-09-01
00810056991302aprevoCarlsmed, Inc.HJW2023-01-09
00850006785070AdaptDx Pro USB-C Headset CableMACULOGIX, INC.OUM2022-01-27
00850006785087AdaptDx Pro USB-C Wall ChargerMACULOGIX, INC.OUM2022-01-27
00850006785001AdaptDxMACULOGIX, INC.OUM2022-01-27
10850006785077AdaptDx Pro USB-C Headset CableMACULOGIX, INC.OUM2022-01-27
10850006785084AdaptDx Pro USB-C Wall ChargerMACULOGIX, INC.OUM2022-01-27
00850006785100AdaptDx Pro InternationalMACULOGIX, INC.OUM2022-01-27
00850006785025AdaptDx Pro USB-C Wall Charger InternationalMACULOGIX, INC.OUM2022-01-26
00850006785018AdapDx ProMACULOGIX, INC.OUM2021-04-09
00850006785032AdaptDx Pro Handheld ControllerMACULOGIX, INC.OUM2021-04-09
00850006785049AdaptDx Pro Eye CupsMACULOGIX, INC.HJW2021-04-09
00850006785056AdaptDx Pro Head Strap linerMACULOGIX, INC.OUM2021-04-09
00850006785063AdaptDx Pro Head StrapMACULOGIX, INC.OUM2021-04-09
10850006785039AdaptDx Pro Handheld ControllerMACULOGIX, INC.OUM2021-04-09
10850006785015AdapDx ProMACULOGIX, INC.OUM2021-04-09
10850006785015AdapDx ProMACULOGIX, INC.HJW2021-04-09
10850006785060AdaptDx Pro Head StrapMACULOGIX, INC.OUM2021-04-09
10850006785060AdaptDx Pro Head StrapMACULOGIX, INC.HJW2021-04-09