Documentation

MARROW CELLUTION

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

CE Certificate – CE 01760 (Production Quality Assurance)  >> view

CE Declaration of Conformity  >> view

MDR (EU 2017/745) Transition Statement  >> view


ISO13485:2016 Certificate – FM 703394 (QM System)  >> view

ISO13485:2016 Certificate – MDSAP 70158 (QM Conformity)  >> view

BSI VerifEye™ verification


US FDA 510(k) Summary  >> view

US FDA Certificate to Foreign Government  >> view

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


Latex & DEHP Statement