Duns Number:968783071
Device Description: A 3 bottle package of Tangible Clean; a multipurpose contact lens solution for gas permeab A 3 bottle package of Tangible Clean; a multipurpose contact lens solution for gas permeable lenses that is approved for use with Tangible Hydra-PEG.
Catalog Number
FG0823
Brand Name
Tangible Clean 3-pack
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
-
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
MRC
Product Code Name
Products, Contact Lens Care, Rigid Gas Permeable
Public Device Record Key
37dd17ae-7418-4d3a-97a1-adea73fe6b01
Public Version Date
December 17, 2019
Public Version Number
2
DI Record Publish Date
November 01, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |