Catalog Number

D80520002R

Brand Name

NA

Version/Model Number

D80520002R

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 04, 2021

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

K945034

Product Code

DSA

Product Code Name

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

Public Device Record Key

59460f21-b34b-48d4-a27e-d9026c56064d

Public Version Date

April 05, 2021

Public Version Number

4

DI Record Publish Date

February 23, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-