Catalog Number

-

Brand Name

SelectaLyte (Sodium Electrode)

Version/Model Number

3910

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K171476

Product Code

JGS

Product Code Name

Electrode, Ion Specific, Sodium

Public Device Record Key

c6a3eabe-aa7e-4e63-9a7e-8eb0ffe8c6fd

Public Version Date

July 04, 2019

Public Version Number

1

DI Record Publish Date

June 26, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-