Duns Number:639571707
Device Description: This cable is used to activate the Nerve Locating mode on the STIMPOD. The red (anode) con This cable is used to activate the Nerve Locating mode on the STIMPOD. The red (anode) connector is designed to clip on to a standard ECG electrode. The 2mm needle connector will accommodate various makes of needles.
Catalog Number
XT-41003
Brand Name
Xavant Technology
Version/Model Number
Nerve Locate Cable
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
2b6e8882-a32b-43ae-96fc-17e8bbf27ca2
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
January 25, 2017
Package DI Number
16009880396082
Quantity per Package
1
Contains DI Package
06009880396085
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 |