Catalog Number

31479549

Brand Name

Kendall

Version/Model Number

31479549

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"

Yes

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

22d134fd-30c4-4eec-ab9b-24663fa9fdc4

Public Version Date

March 22, 2021

Public Version Number

8

DI Record Publish Date

September 24, 2016

Package DI Number

20884527004918

Quantity per Package

50

Contains DI Package

10884527004911

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE