Catalog Number

3140

Brand Name

SEEKER™

Version/Model Number

0305

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

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

DEN150035,DEN150035

Product Code

PPM

Product Code Name

General Purpose Reagent

Public Device Record Key

5158d5c1-fa37-49fb-b804-e9b2c26149f7

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 19, 2017

Package DI Number

10819704020019

Quantity per Package

9

Contains DI Package

00819704020012

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Pack