Duns Number:791387686
Device Description: EZcase Contact Lens Case, Flip Top, 3 Pack
Catalog Number
-
Brand Name
EZcase
Version/Model Number
EZ33
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 29, 2020
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LRX
Product Code Name
Case, Contact Lens
Public Device Record Key
17cc7100-c371-49ea-b00e-2d9a97caec60
Public Version Date
October 30, 2020
Public Version Number
4
DI Record Publish Date
February 22, 2017
Package DI Number
10897522001724
Quantity per Package
72
Contains DI Package
00897522001797
Package Discontinue Date
October 29, 2020
Package Status
Not in Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 3 |