BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    iNSitu Hip System

    DI: 00816127026140 · Model: 10-83-0363 · NEXTSTEP ARTHROPEDIX, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    iNSitu Hip System
    Primary DI
    00816127026140
    Version / Model
    10-83-0363
    Company Name
    NEXTSTEP ARTHROPEDIX, LLC
    Labeler DUNS
    060211165
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-12-16
    Public Version
    1
    Public Version Date
    2024-12-24
    Public Version Status
    New
    Public Device Record Key
    e5a3a2a9-164c-48b4-89bd-fcbd5f493e83

    Device Description

    Acetabular Reamer, Full Hemisphere, Crossbar, 63mm

    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
    HTO Reamer

    GMDN Terms

    Code Name
    32848 Acetabular orthopaedic reamer

    Identifiers

    Type ID
    Primary 00816127026140