Catalog Number

XT-45021D

Brand Name

Xavant Technology

Version/Model Number

STIMPOD NMS450 AMG Only Kit (1.8m)

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,K102084,K102084,K102084

Product Code

BXN

Product Code Name

Stimulator, Nerve, Battery-Powered

Public Device Record Key

b73bf884-1981-4e3c-865c-2433d7fc9226

Public Version Date

August 26, 2021

Public Version Number

1

DI Record Publish Date

August 18, 2021

Package DI Number

16009880396785

Quantity per Package

1

Contains DI Package

06009880396788

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box