BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Integra®

    DI: 10381780242369 · Model: BRH20030P · Ascension Orthopedics, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Integra®
    Primary DI
    10381780242369
    Version / Model
    BRH20030P
    Catalog Number
    BRH-200-30P
    Company Name
    Ascension Orthopedics, Inc.
    Labeler DUNS
    942377524
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-08-30
    Public Version
    4
    Public Version Date
    2023-01-25
    Public Version Status
    Update
    Public Device Record Key
    212a5d70-80e7-4e6b-8148-83d87473e286
    Distribution End Date
    2026-12-31

    Device Description

    PyroCarbon PIP Total Joint PIP Proximal Broach Sz. 30

    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
    Yes
    Has Donation ID
    No

    Sterilization

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

    Product Codes

    Code Name
    HTQ BROACH

    GMDN Terms

    Code Name
    36167 Orthopaedic broach

    Identifiers

    Type ID
    Secondary M269BRH20030P1
    Primary 10381780242369

    Customer Contacts

    Phone
    +1(800)654-2873
    Email
    [email protected]

    Device Sizes

    Type Value Unit Text
    Device Size Text, specify Size 30