BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Ambler Surgical

    DI: 00190660155834 · Model: Tennant nucleus rotator · 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
    00190660155834
    Version / Model
    Tennant nucleus rotator
    Catalog Number
    9221E
    Company Name
    AMBLER SURGICAL CORP.
    Labeler DUNS
    015272206
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-01-07
    Public Version
    2
    Public Version Date
    2021-06-08
    Public Version Status
    Update
    Public Device Record Key
    37570dce-0283-41b6-9cbd-45cbab08fccc

    Device Description

    Tennant nucleus rotator, 4 5/8'', angled shaft, 10.0mm from bend to tip, 0.37mm diameter ball shaped tip, round 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
    Yes
    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
    HNQ Hook, ophthalmic

    GMDN Terms

    Code Name
    12036 Eye muscle hook, reusable

    Identifiers

    Type ID
    Primary 00190660155834

    Customer Contacts

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