Duns Number:072943876
Device Description: Contact Lens Case intended for storage of soft (hydrophilic), rigid gas permeable or hard Contact Lens Case intended for storage of soft (hydrophilic), rigid gas permeable or hard contact lenses during chemical disinfection. Not to be used during heat disinfection.
Catalog Number
003680029669
Brand Name
Top Care Contact Lens Case
Version/Model Number
C283TC
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)
-
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
40ba7f0a-d544-49b0-8fa3-3e8053242772
Public Version Date
June 14, 2018
Public Version Number
3
DI Record Publish Date
August 05, 2016
Package DI Number
10036800296692
Quantity per Package
6
Contains DI Package
20036800296699
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 | 29 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |
| U | Unclassified | 1 |