Duns Number:610954729
Device Description: Alpha-Stim Conducting Solution 250 ml
Catalog Number
-
Brand Name
Alpha-Stim Conducting Solution
Version/Model Number
SL250
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
54110224-6c79-4b35-bf23-3640db5f1e48
Public Version Date
February 21, 2022
Public Version Number
2
DI Record Publish Date
November 30, 2021
Package DI Number
00857869005291
Quantity per Package
48
Contains DI Package
00857869005284
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
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 |