Duns Number:141732011
Device Description: LG PGD Biopsy Medium 50 ml
Catalog Number
LPGG-050
Brand Name
LifeGlobal® Media
Version/Model Number
LPGG-050
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 13, 2020
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
K040530
Product Code
MQL
Product Code Name
MEDIA, REPRODUCTIVE
Public Device Record Key
7f42ac11-4690-4019-b097-689a4f7a0843
Public Version Date
July 13, 2020
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 |