BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Integra® Miltex®

    DI: 10381780510437 · Model: 017-23180 · INTEGRA LIFESCIENCES PRODUCTION CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Integra® Miltex®
    Primary DI
    10381780510437
    Version / Model
    017-23180
    Catalog Number
    017-23180
    Company Name
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION
    Labeler DUNS
    081277700
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-11-21
    Public Version
    3
    Public Version Date
    2022-07-18
    Public Version Status
    Update
    Public Device Record Key
    a58d8fac-0be0-4f5a-98f6-40f0459838a7
    Distribution End Date
    2022-05-01

    Device Description

    Apex Locator, Mark VII™

    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
    LQY Locator, root apex

    GMDN Terms

    Code Name
    16355 Endodontic apex locator

    Identifiers

    Type ID
    Secondary H834017231800
    Primary 10381780510437

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K032743 000