BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BSKF35LH

    Reg #: 2248608 · FEI: 1000526834 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    335
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    CASE MEDICAL, INC.
    Registration Number
    2248608
    FEI Number
    1000526834
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    50 West St.
    City
    Bloomfield
    State
    NJ
    ZIP
    07003
    Country
    US

    Regulatory Submissions

    510(k) Number
    K240898

    Owner / Operator

    Firm Name
    CASE MEDICAL, INC.
    Operator Number
    9020860
    Address
    50 WEST STREET, --
    City
    Bloomfield
    State
    NJ
    Postal Code
    07003
    Country
    US

    Products

    Device Name Product Code
    Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT
    Wrap, Sterilization FRG

    Proprietary Names

    BSKF35LH BSKL02 KSZ-SC04HGC BSKQ02 9736064 9734863 BSKQ05 KSZ-SC08LGC BES171 IFT02 BOS01 BSKH02 BSKSDF4 CA850S 9734448 BMS04 CSSTR02 KSZ-LTCRDSM KSZ-STRNDFLTR CSSTR011W APC02 KSZ-SC04FGC KSZ-39312D BOS15 BOS02C07 HC02 ITX015 APC03 KSZ-39301AS IQT01 KSZ-SC08QGC BOS02C06 KSZ-LTRNDFLTR ENDOF1T234 HC04 KSZ-39312SB 9736525 CSC011 BSKF15LH KSZ-STSTRIP KSZ-39406AS CSNB01GW CSNB25GW 1847CNTR BOS02C03 BMS02 BSKL04 DT02 KSZ-39301BS KSZ-SC04QGC BOS09T 9736377 9735449 9736529 BOS04B APCR1 1850082 9735218 BOS01S03M 9735255 KSZ-39301C1S BES170 B08K BM04 ENDOH1 1850085 DC03YD ELEVCTRAY KSZ-SCKIT2 BMS05 KSZ-39402AS-RKT FC02 KSZ-39301CS 9736527 CSCCC24 ENDOQ1T456 DC0R HCI03 BOS01R06M BOS02C05 BM01 CSSTR016W CSNL01G CSP015 9736531 APC01 EC07 B02K BMS10 KSZ-STCRDLG KSZ-39312J KSZ-SC04LGC CSNB01W APC04 KSZ-SC05FGC BSKF02 INST06 CSP02 KSZ-27717D APOR2 FCI03 CSNC01G 1850090 9736526 FCL2 BSKL03 9735219 KSZ-39312SV B04 CSR011 BOS01R 9733770 BSKSDQ4 1850081 CSI001 KSZ-SC06LGC BMS12 KSZ-39301CMAC B01K BSKQ15LH BOS02T BOS01R03M KSZ-39311AS ELEVRTRAY BSKSDF3 CSR012 KSZ-STRCTFLTR APER01 9734693 BSKSDH4 BOS04 1850080 BOS10T AK01 9734987 115-0010 B07 ELEVLTRAY BOS11T DC02YD BOS14T BSKH03 31814 KSZ-39302 ENDOQ1T234 BSKW02 CSWA002 CSA011 BSKSDH3 BSKW04 BOS02 BSKQ04 9735231 KSZ-LTRCTFLTR BSKF05 BES002 EC01 BOS02T08 9733771 ENDOQ1 KSZ-39312VMS IMT01 B03K CSC002 CSEKIT12 BMS07 KSZ-27717DS BSKL01 FC04 9734692 BOS02T09 KSZ-39312M ENDOF1T456 BSKQ03 CCW003 BOS16 CCW004 BMS03 BOS02T07 B06 BES004 BSKQ35LH BOS18 9734447 KSZ-39403AS-RKT BOS02T06 CSA012 KSZ-39301HCTS KSZ-39301SR ELEVATRAY ARTHROTRAY1 B03 B01 BM06 CSNB25W CSNC01W BES001 BSKQ01 9736276 9736530 KSZ-39316F BOS17 CSNC25GW 9734445 9734695 CSNB25G CSNC252 KSZ-39312FESS BOS02T01 ENDOF2 115-0020 BM05 CMAX100 CSNL01GW 9734694 CSL02 CSNC25W ENDOQ2 DPY-SCF01 B08 BES003 9736523 BSKF03 DC4GP APSRK01 BSKH15LH CSNB01G BMS01 APC05 KSZ-STCRDSM CSWE002 CSP011 EC05 BM07 KSZ-SC08FGC CSI002 B05 KSZ-39406AS-RKT 9736479 KSZ-39312GSI ARTHROTRAY2 BOS02MOD EC04 APOR1 DPY-SCFM02 9734442 CSNC01GW KSZ-39301SP CSSTR24 BOS01S CSNC25G KSZ-39301TS BOS02C02 EC00 INST09 9736524 BSKH05 CSL014 BSKH35LH BSKF04 BOS04T CSNCD1W CCW001 CSNL01W BOS01R07M BMS08 BOS02C04 9733904 B02 ENDOL1T456 9736382 CSWE03 KSZ-39314FS DT01 BSKH01 BSKSDQ3 BOS04M FC06 BMS06 DC04YD KSZ-39402AS CSC008 9736084 1850091 KSZ-LTCRDLG KSZ-39403AS BM08 CSP012 BOS13T ELEVBTRAY 9734446 B05K APPW2 9736478 BOS01S04M KSZ-39312C BSKF01 BOS01T 9734903 APC09 ENDOL1 CSI003 IHT01 1850083 ENCM BSKH04 KSZ-SCKIT3 KSZ-39301LTA CSA015 BOS12T CA800S ELEVETRAY 1850084 9734841 FC35RTC DC01YD KSZ-STSEAL BOS01S05M EC08 ENDOF1 DC03 KSZ-SC03MGC DC00Y 9735220 EC02 BM03 KSZ-SC03NGC 1850092 KSZ-LTSEAL 9736471 CSNB252 KSZ-SCKIT4 DC01 9736329 KSZ-SCKIT1

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198