Electronic Instructions for Use
The Instructions for Use and related documents available on this website are intended for use by qualified healthcare professionals only. By accessing this webpage, you confirm that you are a qualified healthcare professional.
This webpage provides access to the latest version of each product IFU in electronic format (e-IFU) To ensure proper viewing and printing, we recommend using the latest version of Adobe Acrobat Reader. If you do not have Adobe Acrobat Reader installed, you may download it here.
AMS100/TRU100
Autologous Platelet Separator System Including Associated Disposables
Previous IFU versions below:
MAG200/TRU200
Autologous Platelet Separator System Including Associated Disposables
IFU AMS95067LBL Rev 7
Previous IFU versions below:
AMS300/TRU300
Magellan® Complete Disposable Kit
AMS95023LBL Rev 10
AMS95023LBL Rev 9
MDK300/TRU300-O
Magellan® Autologous Platelet Separator Disposables Kit
AMS95052LBL Rev 6
Previous IFU versions below:
AMS95052LBL Rev 5
AMS95052LBL Rev 4
AMS305
Magellan® Basic Disposable Kit
AMS95024LBL Rev 7
AMS95024LBL Rev 6
AMS310/AMS312
Magellan® Complete One Source Kit
AMS95023LBL Rev 10
AMS95125LBL Rev 3
AMS95023LBL Rev 9
MDK305
Magellan® Basic Platelet Separator Kit
IFU AMS95053LBL Rev 6
Previous IFU versions below:
AMS95053LBL Rev 5
AMS95053LBL Rev 4
AMS314
Magellan® Complete One Source Kit
AMS95023LBL Rev 10
AMS95023LBL Rev 9
AMS350
AMS95024LBL Rev 7
AMS95024LBL Rev 6
AMS505
Magellan® Ratio Dispenser Kit
AMS95125LBL Rev 3
AMS95125LBL Rev 2
MRD505
Magellan® Ratio Dispenser Kit
IFU AMS95124LBL Rev 3
Previous IFU versions below:
AMS95124LBL Rev 2
AMS95124LBL Rev 1
MAR01-O-45/ MAR01-O-80
AMS95300LBL Rev 2
AMS95300LBL Rev 1
CLPT-PK-101/CLPT-PK-101-45
AMS95023LBL Rev 10
AMS95024LBL Rev 7
AMS95140LBL Rev 3
AMS95023LBL Rev 9
MAR0Max
Magellan® MAR0Max Convenience Kit
AMS95125LBL Rev 3
AMS95140LBL Rev 3
AMS95305LBLRev 3
AMS95125LBL Rev 2
MAR0Max45/MAR0Max80
AMS95125LBL Rev 3
AMS95140LBL Rev 3
AMS95305LBL Rev 3
AMS95125LBL Rev 2
MAR01/MAR01-KD
Magellan® Surgical Tools for Erythrocyte & Marrow Preparation Kit
AMS95023LBL Rev 10
AMS95125LBL Rev 3
AMS95140LBL Rev 3
AMS95023LBL Rev 9
MAR01-500
Magellan® MAR01 Convenience Kit
AMS95023LBL Rev 10
AMS95140LBL Rev 3
AMS95023LBL Rev 9
MAR01-ATS
AMS95023LBLRev 10
AMS95140LBL Rev 3
AMS95023LBL Rev 9
TruMAR0
Magellan® TruMAR0 Convenience Kit
AMS95023LBL Rev 10
AMS95140LBL Rev 3
AMS95023LBL Rev 9
VetPRP
Magellan® Basic Disposable Kit
AMS95244LBL Rev 3
AMS95244LBL Rev2
Fibrant Instrument Set
Please note:
Once an e-IFU is downloaded, it will only be valid as of the date and time it was first opened or printed, whichever occurred first. To ensure complete accuracy, the user must verify that they are using the most up-to-date version with each subsequent use. It is recommended that the user download the e-IFU on this webpage with each use.
Upon download, if you are unable to access the e-IFU or if the downloaded file does not appear automatically, please clear your cache or contact Customer Service.
Paper copies of Instructions for Use documents are available upon request. To request a paper copy, please contact Customer Service by email at customerservice@istobiologics.com or telephone at 888.705.4786 and provide the following information:
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Your name
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Telephone number
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Product name or product reference number
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Preferred delivery method: email, fax, standard mail, or priority mail
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Mailing address, email address, or fax number, as applicable
The eIFUs are accessible to users in the United States and in jurisdictions where eIFUs are accepted. Users must follow the labeling requirements applicable in their country.
Learn more about Isto Biologics and view our complete product portfolio.
Learn more about our autologous therapies options.
Learn more about the new Fibrant line comprised of five novel products.
Contact Customer Service for questions regarding your product or IFU.
Phone: 888.705.ISTO
Email: customerservice@istobiologics.com