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
MAR01-OFC
Brand Name
Surgical tools for erythrocyte & marrow preparation kit
Version/Model Number
MAR01-OFC
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 31, 2022
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
210fe2ae-93e5-445b-92c0-c2178d58fcec
Public Version Date
November 01, 2022
Public Version Number
5
DI Record Publish Date
September 09, 2016
Package DI Number
M896MAR01OFC1
Quantity per Package
1
Contains DI Package
M896MAR01OFC0
Package Discontinue Date
October 31, 2022
Package Status
Not 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 |