BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Axium Prime Detachable Coil System

    DI: 00847536038752 · Model: FC-5-20-3D · Micro Therapeutics, Inc.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Axium Prime Detachable Coil System
    Primary DI
    00847536038752
    Version / Model
    FC-5-20-3D
    Company Name
    Micro Therapeutics, Inc.
    Labeler DUNS
    826110710
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-08-15
    Public Version
    2
    Public Version Date
    2021-02-05
    Public Version Status
    Update
    Public Device Record Key
    c1aad4d1-45c9-44d5-a3ca-9bf8f2064dc5

    Device Description

    COIL FC-5-20-3D V05

    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
    MR Conditional
    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
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HCG DEVICE, NEUROVASCULAR EMBOLIZATION
    KRD Device, Vascular, for Promoting Embolization

    GMDN Terms

    Code Name
    60940 Neurovascular embolization coil

    Identifiers

    Type ID
    Primary 00847536038752

    Customer Contacts

    Phone
    +1(800)633-8766
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K162704 000

    Storage Conditions

    Type
    Special Storage Condition, Specify
    Special Conditions
    store in a cool dry place