Catalog Number

6003-436

Brand Name

Selectra

Version/Model Number

ProM

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 23, 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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K102647

Product Code

JGS

Product Code Name

Electrode, Ion Specific, Sodium

Public Device Record Key

906b3853-65d5-4ead-9016-9267fde4c7cc

Public Version Date

December 29, 2021

Public Version Number

5

DI Record Publish Date

November 18, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-