Catalog Number

EL-2MTP

Brand Name

AVANOS

Version/Model Number

39197

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

KOI

Product Code Name

STIMULATOR, NERVE, PERIPHERAL, ELECTRIC

Public Device Record Key

92506323-2c0e-4c78-a0c0-f5122c0c5095

Public Version Date

September 23, 2022

Public Version Number

2

DI Record Publish Date

May 08, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-