BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    K2M Fenestrated Tap System

    DI: 10888857183124 · Model: 5001-90015 · K2M, INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    K2M Fenestrated Tap System
    Primary DI
    10888857183124
    Version / Model
    5001-90015
    Catalog Number
    5001-90015
    Company Name
    K2M, INC.
    Labeler DUNS
    146060863
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-10-24
    Public Version
    4
    Public Version Date
    2019-06-07
    Public Version Status
    Update
    Public Device Record Key
    22cfc4bb-e377-4541-8476-43bf68abf3da

    Device Description

    Tap, Fenestrated, Size Ø6.5 mm

    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
    KNW INSTRUMENT, BIOPSY
    OAR Injector, vertebroplasty (does not contain cement)

    GMDN Terms

    Code Name
    61300 Internal spinal fixation procedure kit, single-use

    Identifiers

    Type ID
    Primary 10888857183124

    Customer Contacts

    Phone
    +1(703)777-3155
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K152872 000