BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Gutta Percha 02-LM-40

    DI: 08806387804338 · Model: 0433 · Meta Biomed Co., Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Gutta Percha 02-LM-40
    Primary DI
    08806387804338
    Version / Model
    0433
    Company Name
    Meta Biomed Co., Ltd.
    Labeler DUNS
    688322841
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-06-01
    Public Version
    2
    Public Version Date
    2021-07-01
    Public Version Status
    Update
    Public Device Record Key
    d344d26b-98ae-4f6d-96ee-1dd5e6f68618

    Device Description

    Gutta Percha Points and Bars Length Marked 02 taper #40, 120Points, P71

    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
    45081 Synthetic gutta-percha

    Identifiers

    Type ID
    Primary 08806387804338