BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    EMERGE MEDICAL & Design

    DI: 00886020028343 · Model: 310.89.EM · EMERGE MEDICAL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    EMERGE MEDICAL & Design
    Primary DI
    00886020028343
    Version / Model
    310.89.EM
    Catalog Number
    310.89.EM
    Company Name
    EMERGE MEDICAL, INC.
    Labeler DUNS
    078642955
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2015-07-08
    Public Version
    4
    Public Version Date
    2018-05-01
    Public Version Status
    Update
    Public Device Record Key
    a0aacd84-d609-43ee-804b-a341fdd31316
    Distribution End Date
    2018-05-01

    Device Description

    COUNTERSINK FOR 3.5MM CORTEX & 4.0MM CANCELLOUS BONE SCREWS

    Device Characteristics

    Single Use
    No
    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
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    LXH ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    GMDN Terms

    Code Name
    16462 Surgical countersink, reusable

    Identifiers

    Type ID
    Primary 00886020028343