LifeGlobal® Media - ALLGrad 90% 50 ml - LIFEGLOBAL GROUP, LLC

Duns Number:141732011

Device Description: ALLGrad 90% 50 ml

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More Product Details

Catalog Number

AG90-050

Brand Name

LifeGlobal® Media

Version/Model Number

AG90-050

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 14, 2021

Issuing Agency

In GS1

Product Characteristics

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

K022330

Product Code Details

Product Code

MQL

Product Code Name

MEDIA, REPRODUCTIVE

Device Record Status

Public Device Record Key

03f29b50-8e0e-4c11-9b2d-b4936eedd80b

Public Version Date

July 14, 2021

Public Version Number

5

DI Record Publish Date

September 21, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"LIFEGLOBAL GROUP, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 155