Duns Number:600070283
Device Description: The APX200 is a single patient, single use device, intended to provide expansion of the pu The APX200 is a single patient, single use device, intended to provide expansion of the pupillary aperture.
Catalog Number
200-300
Brand Name
APX 200
Version/Model Number
200
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"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HNQ
Product Code Name
Hook, Ophthalmic
Public Device Record Key
41aa3f3a-f354-47f0-a61f-883f99e8f272
Public Version Date
April 22, 2021
Public Version Number
1
DI Record Publish Date
April 14, 2021
Package DI Number
27290017069009
Quantity per Package
6
Contains DI Package
17290017069002
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
6 Units Package