BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Inoris Medical Sp. z o.o.

    DI: 05902596226060 · Model: IM-10 Clip-on Biteguard · INORIS MEDICAL SP Z O O
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Inoris Medical Sp. z o.o.
    Primary DI
    05902596226060
    Version / Model
    IM-10 Clip-on Biteguard
    Company Name
    INORIS MEDICAL SP Z O O
    Labeler DUNS
    522725233
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-07-24
    Public Version
    1
    Public Version Date
    2020-08-03
    Public Version Status
    New
    Public Device Record Key
    023b8eeb-7bf6-4398-9731-c3303c57a72d

    Device Description

    Biteblocks for adults

    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
    MR Safe
    Direct Marking Exempt
    Yes
    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
    MNK Endoscopic Bite Block

    GMDN Terms

    Code Name
    10405 Seizure bite block

    Identifiers

    Type ID
    Primary 05902596226060