BEUDAMED
    FDA Registration Active 🇺🇸 United States

    General Surgical Instrument

    Reg #: 1054811 · FEI: 1000114185 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    55
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics U.S. LLC
    Registration Number
    1054811
    FEI Number
    1000114185
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    502 Prairie Mine Rd
    City
    MULBERRY
    State
    FL
    ZIP
    33860
    Country
    US

    Owner / Operator

    Firm Name
    Sotera Health LLC
    Operator Number
    10029425
    Address
    2015 Spring Road, Suite 650
    City
    Oak Brook
    State
    IL
    Postal Code
    60523
    Country
    US
    Correspondent
    Karen Whaley-Krumins

    Products

    Device Name Product Code
    Motor, Surgical Instrument, Ac-Powered GEY

    Proprietary Names

    General Surgical Instrument OSCILL SAWBLADE 1.35MM FAN STRYKR2000 OSC SWBLD VERSIPOWER PLUS OSCIL SAW BLDE 1.35MM FAN HALL 3/4 IN GII SM VERSIPOWER SAWBLAD OSC SWBLD FANNED VERSIPOWER PLUS RECIP BLADE SINGLE SIDED STRYKER GII SAWBL.3/4 IN.MICRO-AIRE STICHSAGEBLATT LINVATEC/HALL RECIP BLADE DOUBLE SIDED STRYKER STICHSAGEBLATT STRYKER RECIPROCATING BLADE DBLE SIDED AO SYN GII SAGEBLATT STRYKER-NEU PROFIX SAWBL.STRYKER S6 NARROW PROFIX SAWBL.STRYKER S6 3/4 IN. PROFIX SAWBL.3/4 IN.MICRO-AIRE OSCILLATING SAW BLADE 1.27MM WIDE HALL GII SMALL 3M SAWBLADE GII SAGEBLATT LINVATEC/HALL PRO SAWBLADE-STRY OLD STY FAN OSCILLATING BLADE 1.27MM WIDE POWERPRO OSC SWBLD 1.27MM NARROW HALL GII SM OLD STRYKER SAWBLD OSCILL SAWBLADE 1.35MM NRW STRYKR ORT OSCILL SWBLADE 1.35MM NRW HALL 1/2 IN PROFIX SAWBL.STRYKER S6 WIDE GII SAGEB.LINVATEC/HALL SCHMAL OSCILLAT SAW BLADE 1.27MM FAN PWRPRO GII SAWBLADE STRYKER S6 WIDE GII SAGEBLATT STRYKER GII Z VERSIPOWER SAWBLADE GII SAGEBLATT AMSCO/HALL OSCILLATING SAW BLADE 1.27MM {} WIDE 3M ACCURIS-TIBIAL INLAY CUTTER OSCILL SAW BLADE 1.27MM FANNED HALL OSCILLATING BLADE 1.27MM NRW POWERPRO RECIPROCATING BLADE SINGLE SIDED HALL PROFIX SAGEBL.3/4 AESC./HOWM. OSC SWBLD FANNED STRYKER ORTHO POWER GII SAWBLADE STRYKER S6 NARROW RECIPRO SAW BLADE SINGLE SIDED AO SYN OSCILLATING SAW BLADE 1.35MM FAN 3M OSCILL SWBLDE 1.35MM NRW {} STRYKR2000 GII SAWBLADE STRYKER S6 3/4 IN. GII SAGEBLATT DE SOUTTER OSCILL SAWBLADE 1.27MM FANNED 3M OSCILL SAWBLADE 1.35MM NARROW 3M OSCILL SAWBLADE 1.35MM FANN PWERPRO RECIPROCATING BLADE DOUBLE SIDED HALL ACCURIS HANDSAGEBLATT 15X135 PROFIX SAGEBL.3/4SYNTH/HOWM.2 OSC SWBLD 1.27MM WIDE STRYKER 2000 GII STRYKER SAWBLADE OSC SWBLD 1.27MM NARROW STRYKER 2000 OSCILL SAWBLADE 1.27MM FAN STRYKR2000

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)