BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CERVICAL SEAL ASSY DEVICE

    DI: 15420045512191 · Model: OLK-100 · Hologic, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    4
    Pkg Device Count
    1

    Basic Information

    Brand Name
    CERVICAL SEAL ASSY DEVICE
    Primary DI
    15420045512191
    Version / Model
    OLK-100
    Catalog Number
    OLK-100
    Company Name
    Hologic, Inc.
    Labeler DUNS
    018925968
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-09-11
    Public Version
    2
    Public Version Date
    2023-08-25
    Public Version Status
    Update
    Public Device Record Key
    c6c8ae82-f032-4589-acfc-9d3edf180c11

    Device Description

    The Omni™ Lok cervical seal is used during a hysteroscopic procedure to minimize liquid distention media leakage from the cervix.

    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
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    Yes
    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
    QHZ Seal, cervical, mechanical, unpowered

    GMDN Terms

    Code Name
    63474 Hysteroscopy cervical leakage sheath

    Identifiers

    Type ID
    Primary 15420045512191
    Package 25420045512198
    Package 35420045512195
    Package 45420045512192

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K191281 000