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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Select Sil Firm Putty

    DI: 07540208000356 · Model: SEL-SIL-FR-B400 · Zendo Direct AG
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Select Sil Firm Putty
    Primary DI
    07540208000356
    Version / Model
    SEL-SIL-FR-B400
    Catalog Number
    SEL-SIL-FR-B400
    Company Name
    Zendo Direct AG
    Labeler DUNS
    486717338
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-07-05
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    6957317f-a02c-4119-8317-c6434dd4ad15

    Device Description

    Kneadable base impression material based on addition curing vinyl silicones - Blue, Regular Set

    Device Characteristics

    Single Use
    No
    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
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    ELW Material, Impression

    GMDN Terms

    Code Name
    35866 Silicone dental impression material

    Identifiers

    Type ID
    Package 17540208000353
    Primary 07540208000356

    Storage Conditions

    Type
    Special Storage Condition, Specify
    Special Conditions
    Storage temperature: max. 77°F (25°C)