Catalog Number

XT-46003

Brand Name

Xavant Technology

Version/Model Number

Nerve mapping 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

K161091,K161091,K161091,K161091,K161091

Product Code

GZJ

Product Code Name

Stimulator, Nerve, Transcutaneous, For Pain Relief

Public Device Record Key

11474a9b-3892-4f6a-9b56-4e264dc668ed

Public Version Date

October 23, 2019

Public Version Number

4

DI Record Publish Date

July 18, 2017

Package DI Number

16009880396037

Quantity per Package

1

Contains DI Package

06009880396030

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box