BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    EndoRotor® Catheter 3.2mm x 1540mm

    DI: 00854172008018 · Model: ER 10-02-O · INTERSCOPE, INC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    EndoRotor® Catheter 3.2mm x 1540mm
    Primary DI
    00854172008018
    Version / Model
    ER 10-02-O
    Catalog Number
    ER 10-02-O
    Company Name
    INTERSCOPE, INC
    Labeler DUNS
    968227913
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-08-02
    Public Version
    2
    Public Version Date
    2024-02-12
    Public Version Status
    Update
    Public Device Record Key
    bd3844dc-60fb-4032-bdf4-c33e566b20c2
    Distribution End Date
    2023-01-01

    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
    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
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    PTE Endoscopic Morcellator Gastroenterology

    GMDN Terms

    Code Name
    46732 Tissue morcellation system handpiece, line-powered

    Identifiers

    Type ID
    Primary 00854172008018

    Customer Contacts

    Phone
    1-800-461-4289
    Email
    [email protected]