Catalog Number

33553

Brand Name

Kendall

Version/Model Number

None

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

-

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

IKD

Product Code Name

CABLE, ELECTRODE

Public Device Record Key

3c5b840d-f330-48b8-89ca-f650a4d41183

Public Version Date

September 20, 2021

Public Version Number

1

DI Record Publish Date

September 11, 2021

Package DI Number

50885380177451

Quantity per Package

100

Contains DI Package

10885380177453

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE