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    FDA UDI In Commercial Distribution 🇺🇸 United States

    OMT LLC

    DI: M73110030 · Model: Pocket Pattie · OMT, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    10

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    Basic Information

    Brand Name
    OMT LLC
    Primary DI
    M73110030
    Version / Model
    Pocket Pattie
    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
    2016-12-30
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    d0003eec-79a3-476f-8ea3-1b8037ebe0dd

    Device Description

    Pocket Pattie; Sterile; X-Ray Detectable; Tissue Compatible Rayon; Tapered Shape; With a Pocket on Tip for Instrument Insertion; 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 M73110030
    Unit of Use 900010

    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