BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Osseo Seal

    DI: D914OSS100040 · Model: OSS-1000-40 · ODONTIT S.A.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Osseo Seal
    Primary DI
    D914OSS100040
    Version / Model
    OSS-1000-40
    Company Name
    ODONTIT S.A.
    Labeler DUNS
    972044937
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-04-20
    Public Version
    1
    Public Version Date
    2023-04-28
    Public Version Status
    New
    Public Device Record Key
    0d9649fa-8565-476b-930d-38734529ac86
    Distribution End Date
    2023-04-20

    Device Description

    Osseo Seal 4.0 cc Bovine bone graft 250-1000 micron vial

    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
    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    NPM Bone Grafting Material, Animal Source

    GMDN Terms

    Code Name
    47968 Dental bone matrix implant, animal-derived

    Identifiers

    Type ID
    Primary D914OSS100040