Duns Number:658826479
Device Description: 6 sterile daily wear soft contact lenses, 45% Ocufilcon D, 55% water.
Catalog Number
-
Brand Name
ArtMost SoftOK Daily Wear Soft Contact Lens
Version/Model Number
STC/-12.50D
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
-
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
K141280,K141280
Product Code
LPL
Product Code Name
Lenses, Soft Contact, Daily Wear
Public Device Record Key
1e937d76-abfa-4004-bd39-cca3975d4c80
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
May 08, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-