Duns Number:639571707
Device Description: The STIMPOD NMS415 is a precision nerve mapping tool used for localizing specific neural p The STIMPOD NMS415 is a precision nerve mapping tool used for localizing specific neural pathways. Localization of nerves by electrical stimulation involves connecting the nerve stimulator to the nerve mapping probe. The distance of the nerve mapping probe from the nerve can be estimated by establishing the minimum threshold current required, to facilitate a neuromuscular response.
Catalog Number
XT-41501
Brand Name
Xavant Technology
Version/Model Number
STIMPOD NMS415 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
0ce80037-db0c-4bd6-b716-c603111784a4
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 26, 2016
Package DI Number
16009880396020
Quantity per Package
1
Contains DI Package
06009880396023
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 |