Duns Number:785335381
Device Description: Centrifuge; E8 Porta-Fuge variable; 8-pl, 3500, timer, car seat, cig plug (12v CAR)
Catalog Number
E8C-U8AV-150P
Brand Name
LW Scientific, Inc`
Version/Model Number
E8C-U8AV-150P
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JQC
Product Code Name
Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
Public Device Record Key
a5fe34b1-9796-4083-9c02-e6192faa73c2
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
April 07, 2021
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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 94 |
2 | A medical device with a moderate to high risk that requires special controls. | 28 |