Duns Number:639571707
Device Description: The STIMPOD NMS 410 is a precision nerve locating tool used for localizing specific neural The STIMPOD NMS 410 is a precision nerve locating tool used for localizing specific neural pathways. Localization of nerves by electrical stimulation involvesconnecting the nerve stimulator to a conducting needle through which local anaesthetics can be injected. The distance of the needle (cathode) from the nerve canbe estimated by establishing the minimum threshold current required, to facilitate a neuromuscular response.
Catalog Number
XT-41001
Brand Name
Xavant Technology
Version/Model Number
STIMPOD NMS410 Kit
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
K093591,K093591,K093591,K093591,K093591
Product Code
BXN
Product Code Name
Stimulator, Nerve, Battery-Powered
Public Device Record Key
285143fe-342d-4481-b707-d977cb26adae
Public Version Date
August 30, 2018
Public Version Number
4
DI Record Publish Date
June 13, 2017
Package DI Number
16009880396075
Quantity per Package
1
Contains DI Package
06009880396078
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |