BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Integra® Miltex®

    DI: 10381780168959 · Model: 015-99600 · 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
    10381780168959
    Version / Model
    015-99600
    Catalog Number
    015-99600
    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
    2018-09-12
    Public Version
    4
    Public Version Date
    2020-07-21
    Public Version Status
    Update
    Public Device Record Key
    5bea1415-cd34-45f2-8b2e-ff503b9823e1
    Distribution End Date
    2020-03-31

    Device Description

    Chiropractic Mallet

    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
    Yes
    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
    No

    Product Codes

    Code Name
    LXM MANIPULATOR, PLUNGER-LIKE JOINT

    GMDN Terms

    Code Name
    63426 Joint/spinal manipulator, mechanical

    Identifiers

    Type ID
    Secondary H834015996000
    Primary 10381780168959

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K950646 000