Duns Number:445878788
Device Description: Limited output transcutaneous piezoelectric stimulator for skin reactions associated with Limited output transcutaneous piezoelectric stimulator for skin reactions associated with insect bites.
Catalog Number
-
Brand Name
Tecnibrands
Version/Model Number
Click
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OSG
Product Code Name
Piezo-Electric Stimulator For Relief Of Mosquito Bite Itch
Public Device Record Key
3a1c396f-864d-41ab-8702-3c8296e92d1d
Public Version Date
August 20, 2020
Public Version Number
5
DI Record Publish Date
August 02, 2017
Package DI Number
00182097000313
Quantity per Package
320
Contains DI Package
00182097000023
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
carton box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 8 |