Duns Number:081063873
Device Description: 1-Day Ocylens (etafilcon A) Daily Disposable Soft Contact Lenses
Catalog Number
-
Brand Name
Ocylens
Version/Model Number
01
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LPL
Product Code Name
Lenses, Soft Contact, Daily Wear
Public Device Record Key
b53b9e62-f591-4766-bfc9-6bc93fb7b91c
Public Version Date
August 27, 2018
Public Version Number
1
DI Record Publish Date
July 27, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-