Duns Number:028594987
Device Description: The Bi-Lens Billboard Case base is fabricated from a low-density polypropylene plastic re The Bi-Lens Billboard Case base is fabricated from a low-density polypropylene plastic resin. The overall length is approximately 2.240 in.; width is approximately 2.250 in. and height approximately 0.450 in. It has two lens wells that are paired with the Left cap marked with an L and a plain cap for the right well.
Catalog Number
-
Brand Name
Bi-Lens BillBoard
Version/Model Number
750
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
b545dc37-1f5c-4913-96e1-cb759dbee97e
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 |