BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Smart Coil

    DI: 00814548015019 · Model: 400SMTSFT0202 · PENUMBRA, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Smart Coil
    Primary DI
    00814548015019
    Version / Model
    400SMTSFT0202
    Company Name
    PENUMBRA, INC.
    Labeler DUNS
    191077671
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-07-30
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    9d94658f-2883-44ed-b56d-6585b9b428a8

    Device Description

    SmtCoil-Sft, 2x2

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    Yes
    MRI Safety
    MR Conditional
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HCG DEVICE, NEUROVASCULAR EMBOLIZATION

    GMDN Terms

    Code Name
    43980 Embolization implant kit

    Identifiers

    Type ID
    Primary 00814548015019

    Premarket Submissions

    Submission Number Supplement Number
    K143218 000