Catalog Number

MS-IVB

Brand Name

AVANOS

Version/Model Number

41913

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 01, 2022

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

-

Product Code

BXN

Product Code Name

STIMULATOR, NERVE, BATTERY-POWERED

Public Device Record Key

266690e3-724e-450e-afea-28f1dabb400b

Public Version Date

September 23, 2022

Public Version Number

2

DI Record Publish Date

May 07, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-