Catalog Number
-
Brand Name
Cenefom
Version/Model Number
OP-IW01
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"
Yes
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
K082460,K082460,K082460
Product Code
HOZ
Product Code Name
Sponge, Ophthalmic
Public Device Record Key
b4362ea2-8482-451b-8b6b-4965f1a6ecbf
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
March 31, 2017
Package DI Number
04711552929782
Quantity per Package
50
Contains DI Package
04711552929775
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton