Duns Number:610954729
Device Description: Alpha-Stim Probe (AS100)
Catalog Number
-
Brand Name
Alpha-Stim Probe (AS100)
Version/Model Number
Alpha-Stim Probe (AS100)
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)
-
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
7cf1f0bd-a8ee-404a-8693-29c44e168071
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 25, 2014
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
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 |