Duns Number:004416769
Device Description: TC120R- 2" Round" electrodes, white cloth, carbon, plastic zip lock
Catalog Number
TC120R
Brand Name
Therapist’s Choice®
Version/Model Number
TC120R
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GXY
Product Code Name
Electrode, Cutaneous
Public Device Record Key
c0eada14-3937-4c63-b197-8b439ba48794
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
April 19, 2017
Package DI Number
00815290015623
Quantity per Package
5
Contains DI Package
00815290015616
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
master case
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 16 |