BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Primeprint Splint SF 1000g

    DI: EDET044161 · Model: 04416 · DETAX GmbH
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Primeprint Splint SF 1000g
    Primary DI
    EDET044161
    Version / Model
    04416
    Company Name
    DETAX GmbH
    Labeler DUNS
    343947949
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-10-25
    Public Version
    3
    Public Version Date
    2024-10-21
    Public Version Status
    Update
    Public Device Record Key
    c726dd08-1515-44e2-8664-9e5bde3bd629

    Device Characteristics

    Single Use
    Yes
    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
    MR Safe
    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
    DYJ Retainer, Screw Expansion, Orthodontic
    KMY Positioner, Tooth, Preformed
    MQC Mouthguard, Prescription

    GMDN Terms

    Code Name
    43025 Removable dental occlusal splint, custom-made

    Identifiers

    Type ID
    Primary EDET044161