Duns Number:106793995
Device Description: Centrifuge, Micro, Refrigerated, 24-Place, High Speed, 230v, 50Hz, UK Plug (Includes: 24-P Centrifuge, Micro, Refrigerated, 24-Place, High Speed, 230v, 50Hz, UK Plug (Includes: 24-Place Rotor with Lid for 1.5mL and 2.0mL Microcentrifuge Tubes #MC-24-2ML)
Catalog Number
-
Brand Name
Globe Scientific
Version/Model Number
GCM-R-24-UK
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"
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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
e18cd357-a98d-4831-8a2c-108b344db431
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
November 26, 2019
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 | 184 |
2 | A medical device with a moderate to high risk that requires special controls. | 3 |