Catalog Number

401778

Brand Name

SJM™

Version/Model Number

401778

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

-

Product Code

DSA

Product Code Name

CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)

Public Device Record Key

bae697cd-ae1a-455f-a307-cf8f59b3f78d

Public Version Date

September 21, 2020

Public Version Number

4

DI Record Publish Date

August 06, 2015

Package DI Number

15414734009673

Quantity per Package

5

Contains DI Package

05414734009676

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-