BEUDAMED
    12 results · 36ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    SteriGear, LLC

    FDA registration
    SteriGear, LLC·1 product·🇺🇸 United States

    SteriGear

    FDA UDI
    Sterigear, LLC·00851616002465·Fig Leaf 1000ml Leg Bag 10280

    SteriGear

    FDA UDI
    Sterigear, LLC·00851616002038·Fig Leaf Leg Bag 10272

    SteriGear

    FDA UDI
    Sterigear, LLC·00851616002076·Fig Leaf Foley Catheter Kit 18 Fr. 10279

    SteriGear

    FDA UDI
    Sterigear, LLC·00851616002571·Fig Leaf Low 15 1500ml 10287

    SteriGear

    FDA UDI
    Sterigear, LLC·00851616002021·Fig Leaf Lite 10273

    SteriGear

    FDA UDI
    Sterigear, LLC·00851616002564·Twin Fig Leaf 2000ml 10286

    SteriGear

    FDA UDI
    Sterigear, LLC·00851616002014·Fig Leaf Foley Catheter Kit 16 Fr. 10274

    SteriGear

    FDA UDI
    Sterigear, LLC·00851616002007·The Fig Leaf 10270

    STERIGEAR URINARY DRAIN BAG

    FDA Adverse Event
    Malfunction ·STERIGEAR, LLC·Product code FCN·June 15, 2017

    SteriGear Urinary Drain Bag with Fig Leaf Cover, 2000 ml, REF 10270, The Fig Leaf, SteriGear 362 S. University Avenue, provo, UT 84601, 1-800-398-3259, SteriGear.com, Sterile, EO Urinary Drainage Collection Kit, for Indwelling Catheter. This device is intended to collect the Urine drained from an indwelling catheter

    FDA Recall
    Terminated ·SteriGear, LLC·Product code FCN·January 11, 2011

    SteriGear Urinary Drain Bag with Fig Leaf Cover, 2000 ml, REF 10270, The Fig Leaf, SteriGear 362 S. University Avenue, provo, UT 84601, 1-800-398-3259, SteriGear.com, Sterile, EO Urinary Drainage Collection Kit, for Indwelling Catheter. This device is intended to collect the Urine drained from an indwelling catheter

    FDA Enforcement
    Class II ·Terminated·SteriGear, LLC·July 2, 2014