Duns Number:436234054
Device Description: Pantos C8 SC131_ Silver Petrol Blue/Clear Demo - B4.5 : 46 * 26 148
Catalog Number
-
Brand Name
TAVAT Eyewear
Version/Model Number
SC131_46SPB
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HQZ
Product Code Name
Frame, Spectacle
Public Device Record Key
80249b24-bd5c-4b61-bba7-a1be81d7bea3
Public Version Date
August 09, 2022
Public Version Number
1
DI Record Publish Date
August 01, 2022
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 | 122 |