Duns Number:421287342
Device Description: Angel-40-2x2 pigtails used for tens/ ems machine
Catalog Number
-
Brand Name
Angel
Version/Model Number
Angel-40-2x2 pigtails electrodes
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
November 10, 2025
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
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
GXY
Product Code Name
Electrode, Cutaneous
Public Device Record Key
009bb98f-80a1-42dc-a004-c44f945e842b
Public Version Date
February 19, 2021
Public Version Number
2
DI Record Publish Date
November 13, 2020
Package DI Number
16959006303305
Quantity per Package
50
Contains DI Package
06959006303308
Package Discontinue Date
November 09, 2025
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 13 |