BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Integra® Miltex®

    DI: 10381780532422 · Model: PN4 · INTEGRA LIFESCIENCES PRODUCTION CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Integra® Miltex®
    Primary DI
    10381780532422
    Version / Model
    PN4
    Catalog Number
    PN4
    Company Name
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION
    Labeler DUNS
    081277700
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-08-14
    Public Version
    1
    Public Version Date
    2023-08-22
    Public Version Status
    New
    Public Device Record Key
    87c58c36-1740-4b12-8928-bf6854a2406c

    Device Description

    N-Tralig® Intraligamentary Syringe Barrel Cap

    Device Characteristics

    Single Use
    Yes
    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
    EJI Syringe, cartridge

    GMDN Terms

    Code Name
    35869 Dental anaesthesia syringe, intraligamentary

    Identifiers

    Type ID
    Primary 10381780532422

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K142414 000

    Device Sizes

    Type Value Unit Text
    Outer Diameter 12.5 Millimeter
    Length 15 Millimeter

    Storage Conditions

    Type
    Special Storage Condition, Specify
    Special Conditions
    Store suitably packaged and sterilized instruments in a dry, clean, and dust-free environment