Duns Number:141732011
Device Description: ALLGrad 90% 50 ml
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
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
MQL
Product Code Name
MEDIA, REPRODUCTIVE
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
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 155 |