Duns Number:610954729
Device Description: AS-Trodes
Catalog Number
-
Brand Name
AS-Trodes
Version/Model Number
AT7
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GZJ
Product Code Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
Public Device Record Key
889af4f3-b418-448e-827a-1a24d8dbb1b0
Public Version Date
February 19, 2021
Public Version Number
3
DI Record Publish Date
August 25, 2014
Package DI Number
10857869005052
Quantity per Package
10
Contains DI Package
00857869005055
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
autobag
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 10 |
3 | A medical device with high risk that requires premarket approval | 7 |