Duns Number:141732011
Device Description: ALLGrad Wash 100 ml Glass Bottles
Catalog Number
FGWG-100
Brand Name
LifeGlobal® Media
Version/Model Number
FGWG-100
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 06, 2019
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
K023033
Product Code
MQL
Product Code Name
MEDIA, REPRODUCTIVE
Public Device Record Key
0e9d59c8-3d0e-432b-a00a-da0d10ce6dff
Public Version Date
July 01, 2020
Public Version Number
4
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 |