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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Hartmann Cup Forceps 3mm/9cm

    DI: G25010092120 · Model: 10-092-12 · N S SURGICAL COMPANY
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Hartmann Cup Forceps 3mm/9cm
    Primary DI
    G25010092120
    Version / Model
    10-092-12
    Catalog Number
    10-092-12
    Company Name
    N S SURGICAL COMPANY
    Labeler DUNS
    645681649
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-04-29
    Public Version
    1
    Public Version Date
    2023-05-08
    Public Version Status
    New
    Public Device Record Key
    f39314ac-e672-4594-8efc-a38810e2659e

    Device Description

    A long, thin, hand-held manual surgical instrument designed to facilitate grasping and manipulation of soft-tissues/anatomical structures [typically during ear/nose/throat (ENT) surgery]; it is not intended for insertion through an endoscope, nor into the eye, and is not a dedicated biopsy device. Commonly referred to as alligator- or crocodile-forceps, it has a slender body (to allow for restricted access) and small grasping blades which are hinged close to the distal (working) end. It is a metallic device available in various sizes/lengths; some types may include an integrated suction channel. This is a reusable device intended to be sterilized prior to use.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    ["Ultraviolet Light", "Ethylene Oxide", "Moist Heat or Steam Sterilization"]

    Product Codes

    Code Name
    KAE Forceps, Ent

    GMDN Terms

    Code Name
    62467 Surgical soft-tissue manipulation forceps, alligator, reusable

    Identifiers

    Type ID
    Primary G25010092120

    Device Sizes

    Type Value Unit Text
    Length 9 Centimeter
    Device Size Text, specify Cup Size 3mm