BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SELF-SPAN

    DI: 00841494104634 · Model: ESS144 · Cynosure, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    3

    Basic Information

    Brand Name
    SELF-SPAN
    Primary DI
    00841494104634
    Version / Model
    ESS144
    Catalog Number
    ESS144
    Company Name
    Cynosure, LLC
    Labeler DUNS
    780318028
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    3
    Record Status
    Published
    Publish Date
    2016-09-21
    Public Version
    4
    Public Version Date
    2023-01-11
    Public Version Status
    Update
    Public Device Record Key
    0060da94-51a2-4274-8771-e4b89bdc90ef

    Device Description

    SELF-SPAN (3/PK) CHEEK & LIP RETRACTORS

    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
    Yes
    PM Exempt
    Yes
    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
    EIG RETRACTOR, ALL TYPES

    GMDN Terms

    Code Name
    13380 Hand-held dental retractor

    Identifiers

    Type ID
    Primary 00841494104634
    Unit of Use 00841494106737