MedPark Regeneration First

PRODUCT

Keywords

Scalable to All Aspects of Bone Medicine, S1 Medical

  1. Keywords

    Sticky & Build up
    Moldable & Customizing
    Adjustable to intensity
    Adhesive

Technical Data

Bonegraft solutions for Clinicians and Patients

Bonegraft solutions for Clinicians and Patients

  1. Intended Use

    This product is a sterilized disposable medical device (Gamma sterilization)

  2. Preoperative Preparation

    1) Deliver a double packed product to the operating room while keeping it sterilized. 2) Do not use S1 once the sterile package is damaged or opened.
    3) Do not use S1 bone graft after the expiration date. The validity period is 5(five) years from the date of manufacture.
    4) Read and fully understand 'Directions for Use' before surgery and be sure that surgeon knows exactly how to use S1.

  3. Directions for Use

    1.Open the product aseptically using hands in medical gloves or sterilized medical device.
    2. Before using this product, check the surgical site to be transplanted and rinse thoroughly with sterile water or normal saline.
    3. Before using this product, hydrate with normal saline or blood to achieve the desired shape and then fill in the defect area.
    4. Apply it to the surgical site using an instrument and press it down.
    5. After filling the graft, cover the surgical site and suture it using suture thread.

    * The amount applied to the surgical site and the healing period can be adjusted depending on the judgment of the surgeon.

  4. Storage and Expiration date

    This product is supplied in a sterile container. Store as it is at room temperature
    (1℃ to 30℃) in the shade before use.
    If the sterile packaging is damaged or opened, the product must not be used.
    The contents of the blister package or vial are designed for single use only. Discard any unused material after opening.
    Expiration date is 5 years from date of manufacture.
    Do not use and re-sterilize products that have expired.

  5. Precautions

    1. Warnings
    1) Discard any unused material after opening. Never reuse!
    2) Do not use if package is opened or damaged or if expiration date has been exceeded.
    3) This product should only be used by healthcare professional.

    2. Side Effect
    Incompatibility reactions with MedPark S1 cannot be totally excluded.
    Possible complications which may occur with any surgery include swelling at the surgical site, flap sloughing, bleeding, local inflammation, bone loss, infection, or pain.

    3. General Precaution
    1) After opening the packaging, It is recommended to use immediately in order to avoid infection with external bacteria or microorganisms .
    2) Opened and time-lapsed product is highly susceptible to contamination and cannot be re-sterilized, so dispose of it.
    3) Mixing with other products may cause problems.

Manufacturer

MedPark |24, Nakdong-daero 1570 beon-gil, Buk-gu, Busan, Republic of Korea | E-mail : biz@medpark.net

Sepcifications