DEVICE: AdapDx Pro (00850006785018)
Device Identifier (DI) Information
AdapDx Pro
M-1
In Commercial Distribution
MACULOGIX, INC.
M-1
In Commercial Distribution
MACULOGIX, INC.
A headset that is used to measure dark adaptation.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
No | |
No | |
No | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
10024 | Adaptometer |
A 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.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
OUM | Adaptometer (Biophotometer), Software-Based Data Acquisition And Stimulus Generation |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
04ae67be-d532-4edd-bc6e-51c5ee8d94c5
December 14, 2021
2
April 09, 2021
December 14, 2021
2
April 09, 2021
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
10850006785015 | 1 | 00850006785018 | In Commercial Distribution | ||
20850006785012 | 1 | 10850006785015 | In Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined