BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    HYGENIC® Guttapercha Points

    DI: 14260538370232 · Model: H01473 · Coltène/Whaledent GmbH + Co. KG
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    100

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    Basic Information

    Brand Name
    HYGENIC® Guttapercha Points
    Primary DI
    14260538370232
    Version / Model
    H01473
    Catalog Number
    H01473
    Company Name
    Coltène/Whaledent GmbH + Co. KG
    Labeler DUNS
    315494443
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    100
    Record Status
    Published
    Publish Date
    2022-09-22
    Public Version
    2
    Public Version Date
    2025-01-10
    Public Version Status
    Update
    Public Device Record Key
    9d29f1f1-a6db-475a-a10b-b7cb74535ce5

    Device Description

    HYGENIC® Guttapercha Points Top color ISO 35

    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
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    EKM Gutta-Percha

    GMDN Terms

    Code Name
    34791 Root canal obturating point

    Identifiers

    Type ID
    Unit of Use 04260538370235
    Primary 14260538370232

    Customer Contacts

    Phone
    +4973458050
    Email
    [email protected]

    Storage Conditions

    Type
    Special Storage Condition, Specify
    Special Conditions
    keep dry
    Type
    Special Storage Condition, Specify
    Special Conditions
    keep away from sunlight
    Type
    Storage Environment Temperature
    Temperature Range
    – 25 Degrees Celsius
    Type
    Storage Environment Temperature
    Temperature Range
    – 77 Degrees Fahrenheit