Duns Number:332755078
Device Description: The plusoptiX 16 is a hand held autorefractor and measures refractive data, pupil size, pu The plusoptiX 16 is a hand held autorefractor and measures refractive data, pupil size, pupil distance and gaze deviation in real time. Both eyes are measured at the same time (binocular) at a distance of one meter (3.3 ft) to the patient eyes.
Catalog Number
A16
Brand Name
plusoptiX 16
Version/Model Number
A16
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
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For Single-Use
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Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HKO
Product Code Name
Refractometer, Ophthalmic
Public Device Record Key
fb7bd5c0-747a-4374-b940-22dd731d4183
Public Version Date
October 28, 2022
Public Version Number
1
DI Record Publish Date
October 20, 2022
Package DI Number
04260184514120
Quantity per Package
2
Contains DI Package
04260184514113
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-