Duns Number:639571707
Device Description: The STIMPOD NMS 450 is a precision nerve locating tool used for localizing specific neural The STIMPOD NMS 450 is a precision nerve locating tool used for localizing specific neural pathways. Localization of nerves by electrical stimulation involves connecting the nerve stimulator to a conducting needle through which local anaesthetics can be injected. The distance of the needle (cathode) from the nerve can be estimated by establishing the minimum threshold current required, to facilitate a neuromuscular response. The STIMPOD (NMS 450) includes Neuromuscular Blocking Agent Monitoring functionality with real-time feedback achieved by tri-axial accelerometry.
Catalog Number
XT-45021
Brand Name
Xavant Technology
Version/Model Number
STIMPOD NMS450 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
K102084,K102084,K102084,K102084,K102084
Product Code
BXN
Product Code Name
Stimulator, Nerve, Battery-Powered
Public Device Record Key
33ee9b4e-6fd0-4f08-9f3f-45226d4594fe
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
January 30, 2018
Package DI Number
46009880396311
Quantity per Package
2
Contains DI Package
36009880396314
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 |