Duns Number:141732011
Device Description: LG µPipets®: Injection ICSI 35° w spike - BLUE (1pc)
Catalog Number
MPIC-35*01*
Brand Name
LifeGlobal® Micropipet
Version/Model Number
MPIC-35*01*
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 31, 2018
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
Yes
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
-
Product Code
MQJ
Product Code Name
MICROMANIPULATORS AND MICROINJECTORS, ASSISTED REPRODUCTION
Public Device Record Key
35ac0e31-4bfb-4f41-afcd-0a053cdba10c
Public Version Date
July 03, 2020
Public Version Number
4
DI Record Publish Date
September 23, 2016
Package DI Number
00815965022116
Quantity per Package
10
Contains DI Package
00815965021928
Package Discontinue Date
October 31, 2018
Package Status
Not in Commercial Distribution
Package Type
box,MPIC-35
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 155 |