Duns Number:004416769
Device Description: TC5050-WC- 2"x2" electrodes, white cloth, carbon, plastic zip lock
Catalog Number
TC5050-WC
Brand Name
Clinical Health Services, Inc.
Version/Model Number
TC5050-WC
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
-
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
cf78974e-85d4-45fc-9439-d017fccd8360
Public Version Date
February 19, 2021
Public Version Number
2
DI Record Publish Date
February 12, 2020
Package DI Number
10815290016740
Quantity per Package
10
Contains DI Package
00815290016743
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Poly Pack
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 16 |