Duns Number:196603781
Device Description: Soft Contact Lens Disinfecting Solution, Two 10 and One 2 FL OZ Bottles, 1 Lens Case
Catalog Number
FCP-4278A
Brand Name
Bausch + Lomb
Version/Model Number
623944
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LYL
Product Code Name
Accessories, Solution, Ultrasonic Cleaners For Lenses
Public Device Record Key
3659ceb5-f0fc-4b1d-aa89-d21e395a3e43
Public Version Date
January 17, 2019
Public Version Number
1
DI Record Publish Date
December 17, 2018
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 77 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 134 |
| 3 | A medical device with high risk that requires premarket approval | 3348 |
| U | Unclassified | 1 |