Catalog Number

40000032

Brand Name

Kendall

Version/Model Number

40000032

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

-

Product Code

HGP

Product Code Name

ELECTRODE, CIRCULAR (SPIRAL), SCALP AND APPLICATOR

Public Device Record Key

39df8e9e-99fc-4b5d-8b5f-d4de2c5db38b

Public Version Date

October 26, 2020

Public Version Number

7

DI Record Publish Date

September 24, 2016

Package DI Number

20884521081120

Quantity per Package

50

Contains DI Package

10884521081123

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE