Duns Number:785335381
Device Description: E8 Digital Portafuge Centrifuge
Catalog Number
E8C-U8AD-15TP
Brand Name
LW Scientific, Inc
Version/Model Number
E8C-U8AD-15TP
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 07, 2022
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
84c2c115-ae0c-40e7-887d-fefdffcb4564
Public Version Date
September 08, 2022
Public Version Number
3
DI Record Publish Date
April 08, 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 |