Catalog Number

GHSA-005

Brand Name

LifeGlobal® Media

Version/Model Number

GHSA-005

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K083509,K083509

Product Code

MQL

Product Code Name

MEDIA, REPRODUCTIVE

Public Device Record Key

9192e335-d0cf-4523-97b3-9c319bfcd13d

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 21, 2016

Package DI Number

00815965021362

Quantity per Package

12

Contains DI Package

00815965020693

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box, GHSA-125