Duns Number:595361724
Device Description: Sentosa SX101 is an automated pipetting instrument designed for contamination-free, precis Sentosa SX101 is an automated pipetting instrument designed for contamination-free, precise and correct measuring and transferring of liquids.
Catalog Number
400089
Brand Name
Sentosa SX101
Version/Model Number
400089
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
JQW
Product Code Name
Station, Pipetting And Diluting, For Clinical Use
Public Device Record Key
a96a44f2-4f43-4390-931f-bc32784d9a5f
Public Version Date
September 16, 2022
Public Version Number
2
DI Record Publish Date
January 18, 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 | 15 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 9 |