Duns Number:968783071
Device Description: Tangible Boost is a monthly treatment to restore the Tangible Hydra-PEG® coating, and main Tangible Boost is a monthly treatment to restore the Tangible Hydra-PEG® coating, and maintain the wettability of Tangible Hydra-PEG coated fluorosilicone acrylate rigid gas permeable lenses. Tangible Boost is intended for prescription (Rx) use only.
Catalog Number
FG6
Brand Name
Tangible Boost
Version/Model Number
A
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
Yes
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
DEN200002
Product Code
QMM
Product Code Name
Hydrophilic Re-Coating Solution
Public Device Record Key
7d934724-03a7-44a2-bdad-ec6bba12d404
Public Version Date
February 09, 2021
Public Version Number
1
DI Record Publish Date
February 01, 2021
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. | 4 |