BEUDAMED
    FDA Registration Active 🇺🇸 United States

    3006-20 DORO® Disposable Skull Pin Titanium,Adult (36 pcs)

    Reg #: 1054811 · FEI: 1000114185 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    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

    Regulatory Submissions

    510(k) Number
    K032331

    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
    Holder, Head, Neurosurgical (Skull Clamp) HBL

    Proprietary Names

    3006-20 DORO® Disposable Skull Pin Titanium,Adult (36 pcs) 3006-30 DORO® Disposable Skull Pin Titanium,Pediatric (36 pcs) 1106.103 DORO LUCENT® Disposable Skull Pins Adult, sterile, 9 pcs 110603 DORO LUCENT® Disposable Skull Pins, Adult (sterile, 3pcs)

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)