BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CODMAN® GHAJAR GUIDE®

    DI: 10381780514749 · Model: 801185 · INTEGRA LIFESCIENCES PRODUCTION CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    CODMAN® GHAJAR GUIDE®
    Primary DI
    10381780514749
    Version / Model
    801185
    Catalog Number
    80-1185
    Company Name
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION
    Labeler DUNS
    081277700
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-04-01
    Public Version
    4
    Public Version Date
    2023-04-14
    Public Version Status
    Update
    Public Device Record Key
    fa22ba5d-a26e-4924-89f3-6387ad5c467c

    Device Description

    CODMAN® GHAJAR GUIDE® Ventriculostomy Kit

    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HBG DRILLS, BURRS, TREPHINES & ACCESSORIES (MANUAL)

    GMDN Terms

    Code Name
    61798 Ventricular cerebrospinal fluid drainage catheterization kit

    Identifiers

    Type ID
    Primary 10381780514749

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K875018 000