BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    MCGEE PISTON SLIM 6 MM DIAMETER 475 MM LENGTH STAINLESS

    DI: 00821925016088 · Model: 140167 · Gyrus Acmi, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    MCGEE PISTON SLIM 6 MM DIAMETER 475 MM LENGTH STAINLESS
    Primary DI
    00821925016088
    Version / Model
    140167
    Company Name
    Gyrus Acmi, Inc.
    Labeler DUNS
    007198742
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2015-10-24
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    e922dc12-68cf-4e42-92cd-3694476ef6ed

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    MR Conditional
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    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
    ETA Replacement, Ossicular Prosthesis, Total

    GMDN Terms

    Code Name
    33310 Polyethylene craniofacial tissue reconstructive material

    Identifiers

    Type ID
    Primary 00821925016088

    Customer Contacts

    Phone
    18002623540
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K760433 000