BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BAK4511 Single use, sterile procedural tray/kit Jamshidi Bone Marrow Biopsy and Aspiration Tray w/11g, 4

    Reg #: 1058584 · FEI: 1000219637 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    65
    Establishment Types
    1
    Classifications
    2

    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
    K813338

    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
    Biopsy Needle FCG
    Tray, Surgical, Needle FSH

    Proprietary Names

    BAK4511 Single use, sterile procedural tray/kit Jamshidi Bone Marrow Biopsy and Aspiration Tray w/11g, 4 4382ASP Single use, sterile procedural tray/kit Safe-T Biopsy-Plus Tray w/o Biopsy Needle 4380 Single use, sterile procedural tray/kit Biopsy Tary w/oneedle Safe-T PLUS Jamshidi Bone Marrow Biopsy and Aspirstion Tray, 11ga x 4" TJ Biopsy Needle, 15ga TJ Aspiration Needle, inc. Economy Jamshidi Bone Marrow Biopsy Tray, 11g x 4 " Biopsy/Aspiration needle, inc. Lidocaine SN7015X Jamshidi Menghini Soft Tissue Biopsy Tray, 15G, 100MM Jamshidi Bone Marrow Biopsy and Aspirstion Tray, 11ga x 4" TJ Biopsy Needle, 15ga TJ Aspiration Needle, inc. Lidocaine SN7017X BAK4511 Jamshidi Menghini Soft Tissue Biopsy Tray, 15G, 70MM BEK4511 BAK4508 Jamshidi Bone Marrow Biopsy and Aspiration Tray w/11g, 4" needle, 15ga Aspiration Needle Jamshidi Menghini Soft Tissue Biopsy Tray, 17G, 100MM, inc. Lidocaine and sodium chloride Jamshidi Bone Marrow Biopsy Tray, 11 ga x 4" TJ Biopsy/Aspiration Needle, inc. Lidocaine BAK3411 SK7016A 4382A BK1000DF Safe-T Biopsy-Plus Tray w/o Biopsy Needle Safe-T PLUS Jamshidi Crown Bone Marrow Biopsy Tray, 11ga, 4" TJ Biopsy/Asp. Needle with MAC, inc. Lidocaine Economy Jamshidi Bone Marrow Biopsy and Aspiration Tray, 11g x 4" Biopsy/Aspiration Needle, 15ga Aspiration Needle, inc. 4382SP Bone Marrow Biopsy Tray (without Needles), inc. Lidocaine SK1017A BK1000SP SK1015A BEK3411 SN7016X Jamshidi Menghini Soft Tissue Biopsy Tray, 16G, 70MM IL Sternal/Iliac Bone Marrow Aspiration Tray, 18ga Aspiration Needle, inc. Lidocaine SN1015X Jamshidi Crown Bone Marrow Biopsy and Aspiration Tray, 8ga x 4" TJ, 15ga TJ Aspiration Needle, MAC, inc. Lidocaine 4382ADF IL Sternal/Iliac Bone Marrow Aspiration Tray, 15ga Aspiration Needle Jamshidi Bone Marrow Biopsy Tray w/11g, 4" needle, inc. Lidocaine 4380 SK7015A SK7017A Safe-T PLUS Biopsy-Plus Tray w/o Biopsy Needle Safe-T PLUS Jamshidi Bone Marrow Biopsy Tray, 11 ga x 4" TJ Biopsy/Aspiration Needle, inc. Lidocaine Biopsy Plus Tray w/o Needle, inc. Lidocaine Bone Aspiration Tray, 18ga. TJ Aspiration Needle, inc. Lidocaine Jamshidi Bone Marrow Biopsy and Aspiration Tray w/8g, 4" needle, 15ga Aspiration Needle, inc. Lidocaine SN1017X Jamshidi Crown Bone Marrow Biopsy Tray, 11ga, 4" TJ Biopsy/Asp. Needle with MAC, inc. Lidocaine Jamshidi Bone Marrow Biopsy and Aspirstion Tray, 8ga x 4" TJ Biopsy Needle, 15ga TJ Aspiration Needle, 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 and Aspiration Tray, 11ga x 4" TJ, 15ga TJ Aspiration Needle, MAC, inc. Lidocaine Biopsy Tary w/oneedle 4382ASP Economy IL Sternal/Iliac Bone Marrow Aspiration Tray, 15g aspiration needle , Inc. Lidocaine SK1016A Jamshidi Menghini Soft Tissue Biopsy Tray, 16G, 100MM, inc. Lidocaine and sodium chloride BK1000 Bone Aspiration Tray, 15ga. TJ Aspiration Needle, inc. Lidocaine BAK4511DF SN1016X Safe-T PLUS Bone Marrow Biopsy Tray (without Needles), inc. Lidocaine 4382SP Single use, sterile procedural tray/kit Safe-T PLUS Biopsy-Plus Tray w/o Biopsy Needle BAK4508 Single use, sterile procedural tray/kit Jamshidi Bone Marrow Biopsy and Aspiration Tray w/8g, 4 BAK3411 Single use, sterile procedural tray/kit Jamshidi Bone Marrow Biopsy Tray w/11g, 4 4382A Single use, sterile procedural tray/kit Biopsy Plus Tray w/o Needle, inc. Lidocaine BAK2018 Single use, sterile procedural tray/kit IL Sternal/Iliac Bone Marrow Aspiration Tray, 18ga Aspiration Needle, in

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)