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    FDA UDI In Commercial Distribution 🇺🇸 United States

    ThinPrep Imaging System

    DI: 15420045501003 · Model: ThinPrep Imaging System Server · Hologic, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    ThinPrep Imaging System
    Primary DI
    15420045501003
    Version / Model
    ThinPrep Imaging System Server
    Catalog Number
    71702-001
    Company Name
    Hologic, Inc.
    Labeler DUNS
    018925968
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2014-09-02
    Public Version
    5
    Public Version Date
    2024-05-31
    Public Version Status
    Update
    Public Device Record Key
    6d8cbc0e-8298-492a-b113-4178e9adef6e

    Device Description

    Server for use with the ThinPrep® Imaging System to enable review.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    Yes
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    MNM READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED

    GMDN Terms

    Code Name
    36870 Network server

    Identifiers

    Type ID
    Primary 15420045501003

    Customer Contacts

    Phone
    +1(800)442-9892
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    P020002 007

    Storage Conditions

    Type
    Storage Environment Humidity
    Temperature Range
    15 – 95 Percent (%) Relative Humidity
    Type
    Storage Environment Temperature
    Temperature Range
    -28 – 50 Degrees Celsius
    Type
    Handling Environment Humidity
    Temperature Range
    20 – 80 Percent (%) Relative Humidity
    Type
    Handling Environment Temperature
    Temperature Range
    16 – 32 Degrees Celsius