BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Montgomery® Thyroplasty Instrument Set

    DI: 14063107102483 · Model: MT-200 · Boston Medical Products, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Montgomery® Thyroplasty Instrument Set
    Primary DI
    14063107102483
    Version / Model
    MT-200
    Catalog Number
    MT-200
    Company Name
    Boston Medical Products, Inc.
    Labeler DUNS
    131855157
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-08-31
    Public Version
    1
    Public Version Date
    2022-09-08
    Public Version Status
    New
    Public Device Record Key
    a18eb9a2-36fd-4e41-8551-6fb1363e483a

    Device Description

    Contains one each of MT-201, MT-202, MT-203, MT-204, MT-205, MT-206, MT-207, MT-208, MT-209, MT-210, MT-211, MT-212, & MT-213.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    Yes
    MRI Safety
    MR Unsafe
    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
    MIX System, Vocal Cord Medialization

    GMDN Terms

    Code Name
    44067 ENT surgical procedure kit, non-medicated, reusable

    Identifiers

    Type ID
    Primary 14063107102483

    Customer Contacts

    Phone
    1-800-433-2674
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K972317 000

    Storage Conditions

    Type
    Special Storage Condition, Specify
    Special Conditions
    Keep dry
    Type
    Special Storage Condition, Specify
    Special Conditions
    Keep away from sunlight