Catalog Number

-

Brand Name

Eurotrol

Version/Model Number

179.003.010

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 31, 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

K121468,K121468

Product Code

JJY

Product Code Name

Multi-Analyte Controls, All Kinds (Assayed)

Public Device Record Key

c26360f8-9546-4760-9ea1-455c427a3127

Public Version Date

September 16, 2022

Public Version Number

4

DI Record Publish Date

September 12, 2017

Package DI Number

08718734960904

Quantity per Package

10

Contains DI Package

08718734960911

Package Discontinue Date

July 31, 2021

Package Status

Not in Commercial Distribution

Package Type

-