Catalog Number

-

Brand Name

Precision Disposable Products

Version/Model Number

SF08

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 02, 2019

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K041954,K041954

Product Code

DRX

Product Code Name

Electrode, Electrocardiograph

Public Device Record Key

4ef5f15f-9594-4ab9-baba-636bbd091ad5

Public Version Date

June 23, 2020

Public Version Number

4

DI Record Publish Date

November 16, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-