BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Shaver System

    DI: 00850002250206 · Model: SSA-109 · ENTELLUS MEDICAL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Shaver System
    Primary DI
    00850002250206
    Version / Model
    SSA-109
    Company Name
    ENTELLUS MEDICAL, INC.
    Labeler DUNS
    017283879
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-09-25
    Public Version
    3
    Public Version Date
    2023-07-07
    Public Version Status
    Update
    Public Device Record Key
    0cb078e8-d8f6-4c95-9324-fae03a5e10b8

    Device Description

    Shaver Blade Cleaning Brush

    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
    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
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece

    GMDN Terms

    Code Name
    34878 Surgical instrument/endoscope cleaning utensil, reusable

    Identifiers

    Type ID
    Primary 00850002250206