BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BCAM4508 Single use, sterile procedural tray/kit Jamshidi Crown Bone Marrow Biopsy and Aspiration Tray, 8ga x 4" TJ, 15g

    Reg #: 1058584 · FEI: 1000219637 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    19
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics US LLC
    Registration Number
    1058584
    FEI Number
    1000219637
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    10811 Withers Cove Park Drive
    City
    Charlotte
    State
    NC
    ZIP
    28278
    Country
    US

    Regulatory Submissions

    510(k) Number
    K003370

    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
    Instrument, Biopsy KNW

    Proprietary Names

    BCAM4508 Single use, sterile procedural tray/kit Jamshidi Crown Bone Marrow Biopsy and Aspiration Tray, 8ga x 4" TJ, 15g BCAM4511SP Single use, sterile procedural tray/kit Safe-T PLUS Jamshidi Crown Bone Marrow Biopsy and Aspiration Tray, 11 BCAM4511 Single use, sterile procedural tray/kit Jamshidi Crown Bone Marrow Biopsy and Aspiration Tray, 11ga x 4" TJ, 15 BCTM3411 Single use, sterile procedural tray/kit Jamshidi Crown Bone Marrow Biopsy Tray, 11ga, 4" TJ Biopsy/Asp. Needle Safe-T PLUS Jamshidi Crown Bone Marrow Biopsy Tray, 11ga, 4" TJ Biopsy/Asp. Needle with MAC, inc. Lidocaine Jamshidi Crown Bone Marrow Biopsy and Aspiration Tray, 11ga x 4" TJ, 15ga TJ Aspiration Needle, MAC, inc. Lidocaine Safe-T PLUS Jamshidi Crown Bone Marrow Biopsy and Aspiration Tray, 11ga x 4" TJ, 15ga TJ Aspiration Needle, MAC, inc. Li Jamshidi Crown Bone Marrow Biopsy Tray, 11ga, 4" TJ Biopsy/Asp. Needle with MAC, inc. Lidocaine Jamshidi Crown Bone Marrow Biopsy and Aspiration Tray, 8ga x 4" TJ, 15ga TJ Aspiration Needle, MAC, inc. Lidocaine TJM4008 TJM6011 TJM6008 TJM4011 BCAM4508 BCAM4511 BCTM3411 TJM3513 BCAM4511SP BCTM3411SP Single use, sterile procedural tray/kit Safe-T PLUS Jamshidi Crown Bone Marrow Biopsy Tray, 11ga, 4" TJ Biops

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)