Catalog Number

PA-801

Brand Name

NA

Version/Model Number

PA-801

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

DSA

Product Code Name

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

Public Device Record Key

1f29fc43-299e-4cca-8521-ec8a0ee1b0e7

Public Version Date

May 08, 2018

Public Version Number

3

DI Record Publish Date

September 21, 2016

Package DI Number

10813079021275

Quantity per Package

5

Contains DI Package

00813079021278

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Carton