Catalog Number

6003-435

Brand Name

Selectra

Version/Model Number

ProM

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

K102647

Product Code

JGS

Product Code Name

Electrode, Ion Specific, Sodium

Public Device Record Key

b583208b-2c57-4250-abe2-09841dcc03b2

Public Version Date

June 22, 2022

Public Version Number

8

DI Record Publish Date

November 18, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-