Duns Number:526951168
Device Description: MT-11 is a Transcutaneous Electrical Nerve Stimulator, which is used to provide symptomati MT-11 is a Transcutaneous Electrical Nerve Stimulator, which is used to provide symptomatic pain relief for chronic, acute or post operative pain.
Catalog Number
-
Brand Name
MT-11
Version/Model Number
MT-11
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)
Yes
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
a9667974-1dd3-4f02-906a-9e2f7b6b39e8
Public Version Date
October 23, 2019
Public Version Number
3
DI Record Publish Date
December 31, 2017
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. | 25 |