Catalog Number

SBW551

Brand Name

Stable Base

Version/Model Number

W-551

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"

Yes

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

DRX

Product Code Name

Electrode, Electrocardiograph

Public Device Record Key

10a9423e-4601-49a8-849d-2f8ff4f8d127

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 17, 2015

Package DI Number

30861779000254

Quantity per Package

4

Contains DI Package

20861779000257

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case