Duns Number:141732011
Device Description: PVP Medium, 0.2 ml vial
Catalog Number
LPVP-002
Brand Name
LifeGlobal® Media
Version/Model Number
LPVP-002
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 14, 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
K022590,K022590
Product Code
MQL
Product Code Name
MEDIA, REPRODUCTIVE
Public Device Record Key
7815f03a-4a54-4d93-a839-84b86972ef16
Public Version Date
July 01, 2020
Public Version Number
4
DI Record Publish Date
September 21, 2016
Package DI Number
00815965021379
Quantity per Package
5
Contains DI Package
00815965020754
Package Discontinue Date
April 14, 2020
Package Status
Not in Commercial Distribution
Package Type
box, LPVP-502
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 155 |