BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Oxboro™ Pin Cover

    DI: 00887761003149 · Model: 101002PBX · ASPEN SURGICAL PRODUCTS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    2

    Basic Information

    Brand Name
    Oxboro™ Pin Cover
    Primary DI
    00887761003149
    Version / Model
    101002PBX
    Company Name
    ASPEN SURGICAL PRODUCTS, INC.
    Labeler DUNS
    027680821
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    2
    Record Status
    Published
    Publish Date
    2019-06-11
    Public Version
    4
    Public Version Date
    2022-06-10
    Public Version Status
    Update
    Public Device Record Key
    b202e306-d95a-48e1-b7d5-55e012251d01
    Distribution End Date
    2021-12-15

    Device Description

    Single use device intended to cover exposed ends of orthopedic pin and k-wires to help protect the exposed wire from snagging on clothing.

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    Yes
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LXH ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    GMDN Terms

    Code Name
    17812 Needle guard

    Identifiers

    Type ID
    Package 10887761003146
    Primary 00887761003149
    Unit of Use 80887761003145

    Customer Contacts

    Phone
    +1(616)698-7100
    Email
    [email protected]