BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    inspiro Flowable Body i2

    DI: 07640163050417 · Model: 3620 · EDELWEISS DR ag
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    inspiro Flowable Body i2
    Primary DI
    07640163050417
    Version / Model
    3620
    Company Name
    EDELWEISS DR ag
    Labeler DUNS
    486793370
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-10-19
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    69524db6-f48a-48b7-bd88-5f7ca9b4becd

    Device Description

    inspiro Flowable Body i2

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    No

    Product Codes

    Code Name
    EBF Material, Tooth Shade, Resin

    GMDN Terms

    Code Name
    47906 Custom-made dental composite resin kit

    Identifiers

    Type ID
    Primary 07640163050417