BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SPHERO FLEX

    DI: 08059224001791 · Model: SPHERO FLEX BRANEMARK h.2 RIV. TiN · RHEIN 83 SRL
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SPHERO FLEX
    Primary DI
    08059224001791
    Version / Model
    SPHERO FLEX BRANEMARK h.2 RIV. TiN
    Catalog Number
    109BRK2R
    Company Name
    RHEIN 83 SRL
    Labeler DUNS
    439240722
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-12-21
    Public Version
    1
    Public Version Date
    2020-12-29
    Public Version Status
    New
    Public Device Record Key
    dc1305d5-3274-4bb1-9207-e16cf19bcbf5

    Device Description

    The OT Equator is designed as an endosseous dental implant retentive component used to retain a complete or partial denture. The OT Equator is screwed into an endosseous implant in the mandible or maxilla.

    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
    MR Unsafe
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    DZE Implant, Endosseous, Root-Form

    GMDN Terms

    Code Name
    44879 Dental implant suprastructure, permanent, preformed

    Identifiers

    Type ID
    Primary 08059224001791
    Previous D821109BRK2R0