Duns Number:028594987
Device Description: Deep Well Lens Cases are fabricated from a low-density polyethylene plastic resin and have Deep Well Lens Cases are fabricated from a low-density polyethylene plastic resin and have a smooth lens well surface. They are used for the storage and chemical disinfection of hard, GP or soft contact lenses. They are not to be used with heat disinfection.
Catalog Number
-
Brand Name
Deep Well Lens Case (Smooth
Version/Model Number
500
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
-
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
e49d82d3-e64d-417b-a5d0-83f535f9067c
Public Version Date
March 23, 2021
Public Version Number
3
DI Record Publish Date
December 08, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 14 |
| 3 | A medical device with high risk that requires premarket approval | 6 |