Catalog Number

ES500

Brand Name

AVANOS

Version/Model Number

39253

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

K162048

Product Code

KOI

Product Code Name

STIMULATOR, NERVE, PERIPHERAL, ELECTRIC

Public Device Record Key

0b0ac204-07ec-4bf8-a745-74bc84508573

Public Version Date

May 15, 2020

Public Version Number

1

DI Record Publish Date

May 07, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-