BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Pac-Dent

    DI: 00815967022367 · Model: PD-135F · PAC-DENT INTERNATIONAL INC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Pac-Dent
    Primary DI
    00815967022367
    Version / Model
    PD-135F
    Company Name
    PAC-DENT INTERNATIONAL INC
    Labeler DUNS
    959077454
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-08-31
    Public Version
    1
    Public Version Date
    2018-10-01
    Public Version Status
    New
    Public Device Record Key
    af8446e3-1139-4545-bb52-5629fda44da3

    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
    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
    Primary 00815967022367