Duns Number:809012870
Device Description: Sterile Disposable Kit containing single-patient-use components necessary for each platele Sterile Disposable Kit containing single-patient-use components necessary for each platelet separation procedure with the MAGELLAN® Autologous Platelet Separator Instrument.
Catalog Number
BTI900
Brand Name
AUTOSPIN Disposable sterile kit
Version/Model Number
BTI900
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 15, 2020
Issuing Agency
In HIBCC
MRI safety Status
MR Safe
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"
Yes
For Single-Use
Yes
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
-
Product Code Name
-
Public Device Record Key
9919a8bb-ed98-41f8-94a4-8f1655e62304
Public Version Date
July 23, 2020
Public Version Number
5
DI Record Publish Date
September 12, 2016
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 | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 16 |