Duns Number:830437997
Device Description: TENS unit with remote
Catalog Number
-
Brand Name
VERIDIAN
Version/Model Number
22-041
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
NUH
Product Code Name
Stimulator, Nerve, Transcutaneous, Over-The-Counter
Public Device Record Key
4d6df8bf-3855-4fc4-8166-a3a6f524d94d
Public Version Date
February 19, 2021
Public Version Number
6
DI Record Publish Date
September 26, 2016
Package DI Number
10845717007303
Quantity per Package
12
Contains DI Package
30845717007307
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
MASTER CARTON
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 127 |