Duns Number:006959555
Device Description: Contact Lens Case is intended for storage of soft (hydrophilic), rigid gas permeable (RGP) Contact Lens Case is intended for storage of soft (hydrophilic), rigid gas permeable (RGP), or hard contact lenses during chemical disinfection.
Catalog Number
388369
Brand Name
Meijer Econo-Mate Contact Lens Case
Version/Model Number
K1010-03ST
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
-
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
7b03b99c-f202-4c6a-a2bf-2647218d17c3
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
June 07, 2016
Package DI Number
10041250641091
Quantity per Package
24
Contains DI Package
20023185025617
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 37 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 45 |
| U | Unclassified | 1 |