BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Rectoscope equipment

    DI: 08033638800713 · Model: Rectoscope equipment with LED · SAPI MED SPA
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Rectoscope equipment
    Primary DI
    08033638800713
    Version / Model
    Rectoscope equipment with LED
    Catalog Number
    A.4525LINS
    Company Name
    SAPI MED SPA
    Labeler DUNS
    437320088
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-07-27
    Public Version
    2
    Public Version Date
    2023-11-17
    Public Version Status
    Update
    Public Device Record Key
    407f8cfe-541c-4ae9-b2be-2b38f5339040

    Device Description

    Non sterile and disposable equipment made of 250mm rectoscope, grip, insufflator and built-in LED light.

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KDM Sigmoidoscope, Rigid, Non-Electrical

    GMDN Terms

    Code Name
    40502 Optical proctoscope, single-use

    Identifiers

    Type ID
    Package 08033638800720
    Primary 08033638800713

    Premarket Submissions

    Submission Number Supplement Number
    K070915 000