Duns Number:537396330
Device Description: Sorvall ST 40R 230V 50/60Hz
Catalog Number
75004524
Brand Name
Thermo Scientific
Version/Model Number
Sorvall ST 40R
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
KSO
Product Code Name
Centrifuge, Blood-Bank For In Vitro Diagnostic Use
Public Device Record Key
e843b62a-8a2e-4613-9f1e-cef5a3798174
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
September 26, 2018
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 | 156 |
2 | A medical device with a moderate to high risk that requires special controls. | 3 |