BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    BioHorizons

    DI: 00847236007683 · Model: SYPWSC · BIOHORIZONS IMPLANT SYSTEMS, INC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    BioHorizons
    Primary DI
    00847236007683
    Version / Model
    SYPWSC
    Company Name
    BIOHORIZONS IMPLANT SYSTEMS, INC
    Labeler DUNS
    967279910
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-10-26
    Public Version
    1
    Public Version Date
    2020-11-03
    Public Version Status
    New
    Public Device Record Key
    ac8f9133-bbc7-4d49-a283-4a9c541802ee

    Device Description

    Simple Solutions 3.5mm Waxing Sleeve, Crown

    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
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    NDP Accessories, Implant, Dental, Endosseous

    GMDN Terms

    Code Name
    44880 Dental implant suprastructure, temporary, preformed, single-use

    Identifiers

    Type ID
    Primary 00847236007683