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
AMS314
Brand Name
MAGELLAN Complete One Source Kit
Version/Model Number
AMS314
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
492ccb95-ec38-4742-ab2c-9f79f5480a1e
Public Version Date
July 23, 2020
Public Version Number
4
DI Record Publish Date
May 29, 2017
Package DI Number
M896AMS3141
Quantity per Package
1
Contains DI Package
M896AMS3140
Package Discontinue Date
-
Package Status
In Commercial Distribution
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 |