BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Tricera™ Handpiece

    DI: 00859273007021 · Model: R-10002 · RELIGN CORPORATION
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Tricera™ Handpiece
    Primary DI
    00859273007021
    Version / Model
    R-10002
    Catalog Number
    R-10002
    Company Name
    RELIGN CORPORATION
    Labeler DUNS
    080031617
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-02-20
    Public Version
    5
    Public Version Date
    2022-07-04
    Public Version Status
    Update
    Public Device Record Key
    910e9e20-45d4-4487-9dfc-f7638275a2b9
    Distribution End Date
    2020-11-02

    Device Description

    Shaver Handpiece

    Device Characteristics

    Single Use
    No
    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
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Hydrogen Peroxide

    Product Codes

    Code Name
    HRX Arthroscope
    GEI Electrosurgical, Cutting & Coagulation & Accessories

    GMDN Terms

    Code Name
    53617 Arthroscopic shaver system handpiece, electrically-powered

    Identifiers

    Type ID
    Primary 00859273007021

    Customer Contacts

    Phone
    (866) 608-0131
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K162770 000