BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Alamo P, Alamo T

    DI: M6862100T16110 · Model: 2100T-1611 · ALLIANCE PARTNERS LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Alamo P, Alamo T
    Primary DI
    M6862100T16110
    Version / Model
    2100T-1611
    Catalog Number
    2100T-1611
    Company Name
    ALLIANCE PARTNERS LLC
    Labeler DUNS
    962768169
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-01-01
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    1d8cad52-24ea-418a-af10-ff4d64264697

    Device Description

    Paddle Shaver Instrument

    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
    No
    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
    MDM INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

    GMDN Terms

    Code Name
    32850 Orthopaedic knife

    Identifiers

    Type ID
    Primary M6862100T16110

    Customer Contacts

    Phone
    +1(210)314-2525
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K120401 000
    K122047 000
    K140303 000

    Device Sizes

    Type Value Unit Text
    Device Size Text, specify Paddle Shaver Size: 60x3x11mm