BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Ambler Surgical

    DI: 00190660209018 · Model: Micro pituitary MIS rongeur · AMBLER SURGICAL CORP.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Ambler Surgical
    Primary DI
    00190660209018
    Version / Model
    Micro pituitary MIS rongeur
    Catalog Number
    75-198
    Company Name
    AMBLER SURGICAL CORP.
    Labeler DUNS
    015272206
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-01-04
    Public Version
    1
    Public Version Date
    2021-01-12
    Public Version Status
    New
    Public Device Record Key
    ae1b9a64-d6c6-4c7c-9e9b-2abe69f0e5a1

    Device Description

    Micro pituitary MIS rongeur, working length 185.0mm, straight, graduated, 2.0mm cup jaws with micro tooth, ring handle

    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
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    HAE RONGEUR, MANUAL

    GMDN Terms

    Code Name
    35541 Spinal rongeur

    Identifiers

    Type ID
    Primary 00190660209018

    Customer Contacts

    Phone
    +1(888)407-0006 ext. 0
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K081651 000