Catalog Number

AGSS-500

Brand Name

LifeGlobal® Media

Version/Model Number

AGSS-500

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 18, 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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K022335

Product Code

MQL

Product Code Name

MEDIA, REPRODUCTIVE

Public Device Record Key

3ed93b54-d5b1-4303-a24b-6f626107382f

Public Version Date

July 19, 2021

Public Version Number

5

DI Record Publish Date

September 21, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-