Duns Number:008018525
Device Description: OPTI-FREE LENS CASE
Catalog Number
-
Brand Name
OPTI-FREE
Version/Model Number
OPTI-FREE LENS CASE
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
c7a15f23-2d35-4a9b-93d0-0051f84b9506
Public Version Date
January 24, 2022
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
00300650180047
Quantity per Package
24
Contains DI Package
00300650180023
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 250 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 541 |
| 3 | A medical device with high risk that requires premarket approval | 6098 |