Duns Number:141647094
Device Description: FedMedMicFiUVW, with white and UV light, is a small and portable digital dermatoscope with
Catalog Number
BTS-301
Brand Name
WI-FI DERMATOSCOPE WHITE LIGHT/UV
Version/Model Number
BTS-301
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 17, 2022
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ERA
Product Code Name
Otoscope
Public Device Record Key
175512f5-46e3-481d-a709-7e310f49a665
Public Version Date
August 17, 2022
Public Version Number
2
DI Record Publish Date
August 18, 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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 34 |
2 | A medical device with a moderate to high risk that requires special controls. | 1 |