BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    SA Lrg. Repl. Cover 25x50mm, 4Hr, Velashape III

    DI: 07290109950808 · Model: AS8334A · SYNERON MEDICAL LTD
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SA Lrg. Repl. Cover 25x50mm, 4Hr, Velashape III
    Primary DI
    07290109950808
    Version / Model
    AS8334A
    Catalog Number
    AS8334A
    Company Name
    SYNERON MEDICAL LTD
    Labeler DUNS
    532685716
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-26
    Public Version
    6
    Public Version Date
    2023-10-17
    Public Version Status
    Update
    Public Device Record Key
    0253e8b4-f238-4763-914c-f0324e8230e0
    Distribution End Date
    2023-10-16

    Device Description

    SA Lrg. Repl. Cover 25x50mm, 4Hr, Velashape III

    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
    GEI Electrosurgical, Cutting & Coagulation & Accessories

    GMDN Terms

    Code Name
    44832 Multi-modality skin contouring system

    Identifiers

    Type ID
    Primary 07290109950808
    Package 37290109950809
    Package 17290109950805

    Premarket Submissions

    Submission Number Supplement Number
    K122579 000