BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    PeekMed web

    DI: 05600120304818 · Model: v1 · PEEK HEALTH, S.A.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    PeekMed web
    Primary DI
    05600120304818
    Version / Model
    v1
    Company Name
    PEEK HEALTH, S.A.
    Labeler DUNS
    338110102
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-03-20
    Public Version
    2
    Public Version Date
    2025-07-23
    Public Version Status
    Update
    Public Device Record Key
    c6c6f742-60da-4d0c-ae3d-4b6f7f6d5ac2

    Device Description

    PeekMed web is a system that allows healthcare professionals to plan a surgery procedure simulating 2D and 3D environments. In the case of a 3D environment, the healthcare professional can resort to a 3D model generated from a previous imaging study on the patient and 3D digital representations of the implant material to be used during surgery, e.g. screws, fixation plates, or full prosthesis, deriving from several producing companies. The software imports diagnostic imaging studies (e.g. X-rays or Computed Tomography (CT)) from a storage (e.g., CD Rom, local folder). In parallel, there is a database containing digital representations of prosthetic materials (templates) supplied by their respective manufacturers, which offers the possibility of inserting templates during the surgery planning. As PeekMed web is capable of representing the medical images in a 2D and/or 3D environment, performing relevant measurements on those images and also capable of adding templates, it then can perform a total overview of the surgery. Being software it does not interact with any part of the body of the user and/or patient.

    Device Characteristics

    Single Use
    No
    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
    Yes
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LLZ System, Image Processing, Radiological
    QIH Automated Radiological Image Processing Software

    GMDN Terms

    Code Name
    46470 Orthopaedic/craniofacial implantation planning software

    Identifiers

    Type ID
    Primary 05600120304818