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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Exact Medical Manufacturing

    DI: 00852205007977 · Model: EP54-150 · EXACT MEDICAL MANUFACTURING, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Exact Medical Manufacturing
    Primary DI
    00852205007977
    Version / Model
    EP54-150
    Catalog Number
    EP54-150
    Company Name
    EXACT MEDICAL MANUFACTURING, INC.
    Labeler DUNS
    014464314
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-09-06
    Public Version
    1
    Public Version Date
    2018-10-08
    Public Version Status
    New
    Public Device Record Key
    c9abb60f-be38-42bd-8418-69a427963c3a

    Device Description

    Microscope Drape-Leica, Bayonet, 137x381cm - 54"x150"

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    Yes
    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
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KKX Drape, Surgical

    GMDN Terms

    Code Name
    45021 Instrument/equipment drape, single-use, sterile

    Identifiers

    Type ID
    Package 20852205007971
    Package 10852205007974
    Primary 00852205007977

    Customer Contacts

    Phone
    716-681-0866
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K101689 000