Instructions for Use (IFU)
Marrow Cellution:
Package Insert (multi-language): FR, GB/US, DE, ES, IT, NL, PT, DK, SE, FI, GR, PL, TR, HU, CZ
Process Steps: English | Italian | German
Filter Assembly:
Package Insert: English
Additional Documents
Product Labels:
Marrow Cellution™ MC-RAN-11C: view sample label
Marrow Cellution™ MC-RAN-8C: view sample label
Heparin Flush Protocol
Marrow Cellution™ component rinsing instructions & heparin concentration calculation
Declaration of Distinction
Marrow Cellution™ System vs. Standard Biopsy Needle Technology
Regulatory Documents
EU Quality Management System Certificate (EU 2017/745) – MDR 761263 R000 >> view
EC Declaration of Conformity >> view
ISO13485:2016 Certificate – FM 703394 (QM System) >> view
ISO13485:2016 Certificate – MDSAP 70158 (QM Conformity) >> view
US FDA 510(k) Summary >> view
US FDA Certificate to Foreign Government >> view