Duns Number:809012870
Device Description: MAGELLAN® Autologous Platelet Separator System consists of the Platelet Separator Instrume MAGELLAN® Autologous Platelet Separator System consists of the Platelet Separator Instrument and the associated Platelet Rich Plasma Sterile Disposable Kits.
Catalog Number
TRU200
Brand Name
Autologous Platelet Separator
Version/Model Number
TRU200
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
Yes
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
8ad28415-f0dc-47e0-8522-38608600b848
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
September 09, 2016
Package DI Number
M896TRU2001
Quantity per Package
1
Contains DI Package
M896TRU2000
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 16 |