BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Spetzler - OMT

    DI: M731100020 · Model: Neuro Patties · OMT, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    10
    Pkg Device Count
    10

    Let the assistant research this device

    The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Brand Name
    Spetzler - OMT
    Primary DI
    M731100020
    Version / Model
    Neuro Patties
    Catalog Number
    ALL
    Company Name
    OMT, LLC
    Labeler DUNS
    196899772
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    10
    Record Status
    Published
    Publish Date
    2017-02-24
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    1a46fd0a-f258-4dbc-97e5-3fd6dc993291

    Device Description

    Neuro Pattie; Sterile; X-Ray detectable; Tissue Compatible Rayon; For Single Use.

    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
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HBA Neurosurgical Paddie

    GMDN Terms

    Code Name
    32572 Cottonoid pad

    Identifiers

    Type ID
    Primary M731100020
    Unit of Use K900010
    Package M7311100149
    Package M7311100139
    Package M7311100129
    Package M7311100119
    Package M7311100109
    Package M7311100179
    Package M731110199
    Package M7311100199

    Customer Contacts

    Phone
    954-327-5687
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K020736 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    30 – 70 Degrees Fahrenheit
    Type
    Storage Environment Humidity
    Temperature Range
    30 – 60 Percent (%) Relative Humidity