Catalog Number

IEC-NPD1

Brand Name

Neutral Pad

Version/Model Number

IEC-NPD1

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

Yes

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

K123366

Product Code

ODR

Product Code Name

Electrosurgical patient return electrode

Public Device Record Key

76d604ce-24c3-4df9-a016-4af94e8926bd

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 30, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-