BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Monty 3D Plus

    DI: B8961133120 · Model: 11.3312 · REHAdapt Engineering GmbH & Co. KG
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Monty 3D Plus
    Primary DI
    B8961133120
    Version / Model
    11.3312
    Company Name
    REHAdapt Engineering GmbH & Co. KG
    Labeler DUNS
    340146982
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-07-26
    Public Version
    1
    Public Version Date
    2022-08-03
    Public Version Status
    New
    Public Device Record Key
    6faf391e-2c17-46b5-a0d2-113283d8c07d

    Device Description

    M3D wheelchair mount ideal for eye-tracking devices. Tube lengths 300 x 500 x 400 mm (12 x 20 x 16"). UDS-DC and additional 500 mm (20") tube included. Max. load capacity: 6.0 kg (13.2 lbs). Frame clamp not included.

    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
    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
    KNO Accessories, Wheelchair

    GMDN Terms

    Code Name
    61434 Portable active medical device mount

    Identifiers

    Type ID
    Primary B8961133120