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Surgical Kit

Intended Use

It is used for clinical operation in medical institutions.

    product detail

    Intended Patient Populations

    Patients with exudate from wound, which including all age groups.

    Age: no restrictions

    Weight: no restrictions

    Gender: no restrictions

    Nationality: multiple

    Intended user

    Medical professionals in a specialty, clinical nurses

    Intended using environment

    This device is only designed for use in hospitals.

    Potential complications

    Infection;

    Foreign body reaction

    Medical Conditions

    Wound care

    Indications

    Preparation for surgical operation

    Contraindications 

    None

    Cautions

    1)Do not re-use;

    2)Do not use if package is damaged;

    3)Consult instructions for use or consult electronic instructions for use.

    4)Keep away from sunlight, Keep dry

    5)Please inform the manufacturer and competent authority in case of any adverse events related to the device occur.

    6)This product is sterilized with EO and has a shelf life of 3 years. Please use it within the product's shelf life.

    Model /Size

    MG-DP-01, MG-DP-02, MG-DP-03, MG-DP-04, MG-DP-05, MG-DP-06, MG-DP-07, MG-DP-08, MG-DP-09, MG-DP-10

    Storage conditions

    Products should be stored in a sealed, moisture-proof, ventilated and dry place.

    Disposal 

    The product is disposable and should be disposed of according to local medical waste regulations after use.

    Shelf-life

    3 years  

    Sterilization

    The product is sterilized by EO. If the package is damaged, please do not use it

    product detail

    NO.

    Name

    Intended Use

    1

     Sterile Field

    Used to package medical devices

    2

    Drape

    Used to provide a physical barrier to protect the surgical area from contamination

    3

    Gauze Ball without X-ray

    Gauze Ball without X-ray is used to cover/clean wounds or abrasions and absorb their exudates, absorb body-surface exudates. It is only intended to be used as a mechanical barrier; and not contact mucous membrane or manage the micro-environment of injured skin.

    4

    Non-woven gauze ball

    Used for wound and wound cleaning and care

    5

    Cotton Ball

    Used for cleaning skin and wounds.

    6

    Non-woven gauze pads

    Used for surgical or local wound care by medical staff

    7

    Gauze Sponge without X-ray

    Gauze Sponge without X-ray is used to cover/clean wounds or abrasions and absorb their exudates, absorb body-surface exudates. It is only intended to be used as a mechanical barrier; and not contact mucous membrane or manage the micro-environment of injured skin.

    8

    Hand Towel

    Used for wiping hands

    9

    Absorbent Pad

    used to absorb a large amount of exudate and keep the wound and skin surface dry. It is only intended to be used as a mechanical barrier; and not contact mucous membrane or manage the micro-environment of injured skin. It contains CELLULOSE

    10

    Purcotton swabs

    used to cover/clean wounds or abrasions and absorb their exudates, absorb body-surface exudates. It is only intended to be used as a mechanical barrier; and not contact mucous membrane or manage the micro-environment of injured skin.

    11

    Medical Mask

    Sterile Medical mask used for clinical medical personnel wearing during invasive procedures, and providing protection for receiving treatment patients and implementation of invasive operations medical personnel to stop the blood, body fluids and spatter spreading.

    12

    Disposable Examination Gloves

    Used by medical staff to prevent cross infection between patients and users or to handle contaminated medical materials during the examination, diagnosis, and treatment process.

    13

    Plastic forceps

    Used for gripping items during the diagnosis and treatment process

    14

    Disposable scissors

    used to cut dressings

    15

    Plastic Trays

    Used for storing, classifying, and transporting various medical equipment

    16

    PE apron

    Used for effective isolation of pollutants, reducing the chances and risks of infection, and ensuring hygiene in the medical process

    17

    Plastic cup

    Used for temporary storage of iodine or alcohol

    18

    Biohazard Bag

    Used for storing and transporting medical specimens

    product detail

    Signs Description Signs Description Signs Description
     Definitions of Signs01 Trademark of Manufacturer  Definitions of Signs08 Batch number  Definitions of Signs021 Date of Manufacture
     Definitions of Signs02 Medical device  Definitions of Signs010 Model number  Definitions of Signs020 Country of manufacturer
     Definitions of Signs03 Use-by date  Sterilized using ethylene oxide Sterilized using ethylene oxide  Definitions of Signs019 Caution
     Definitions of Signs04 Non-pyrogenic  Definitions of Signs012 Catalogue number  Definitions of Signs018 Unique Device Identifier
     Single sterile barrier system Single sterile barrier system  Double sterile barrier system Double sterile barrier system  Definitions of Signs017 Keep away from sunlight
     Definitions of Signs06 Do not reuse  Definitions of Signs014 Do not use if the package is damaged  Definitions of Signs016 Keep dry
     CE marking of conformity, and Notified Body Code CE marking of conformity, and Notified Body Code  Definitions of Signs09 Authorized representative in the European Community  Definitions of Signs015 Manufacturer

    Manufacturer

    Definitions of Signs015Name: Haian Medigauze Co., Ltd.

    Address: Jiaoxie Industry park,226633Haian, Jiangsu, PEOPLE'S REPUBLIC OF CHINA

    Tel: +86-513-88240958

    E-mail: medigauze@medigauze.com

    SRN: CN-MF-000009960

    European Authorized Representative

    Definitions of Signs015Name: Shanghai International Holding Corp. GmbH (Europe)

    Add: Eiffestrasse 80, 20537 Hamburg, Germany

    E-mail: shholding@hotmail.com

    SRN: DE-AR-000000001

    Incident reporting

    The user and/or patient shall report any serious incident that has occurred in relation to the device to Haian Medigauze Co., Ltd. and the competent authority of the EU Member State in which the user and/or patient is established.