MedPark Regeneration First

PRODUCT

Keywords

Restoration of skin structure and function

  1. Keywords

    Acellular allograft dermis
    Excellent biocompatibility
    Outstanding durability
    150mg

Technical Data

  1. Intended Use

    Skin/Acellular Dermal Matrix (ADM)

  2. Preoperative Preparation

    1) Check the product’s appearance and packaging for any abnormalities.
    2) Open the outer packaging (box) and retrieve the inner packaging (blister).
    3) Inspect the inner packaging (blister) for any abnormalities.
    4) Open the Tyvek sheet of the inner package and remove the sterile syringe and connector, ensuring no contamination.
    5) Tap the powdered product in the syringe to loosen it.
    6) Remove the cap of the syringe, connect the connector, and attach a syringe filled with sterile normal saline to the opposite side of the connector.
    7) Push the plunger of the sterile saline syringe fully into the product syringe.
    8) Hold both syringes and alternately push the plungers until complete hydration is achieved to rehydrate the product.
    9) After rehydration, the product should be implanted by The responsible physician

  3. Directions for Use

    1) Tap the powdered product in the syringe to loosen it.
    2) Remove the cap of the syringe, connect the connector, and attach a syringe filled with sterile normal saline to the opposite side of the connector.
    3) Push the plunger of the sterile saline syringe fully into the product syringe.
    4) Hold both syringes and alternately push the plungers until complete hydration is achieved to rehydrate the product.
    5) After rehydration, the product should be implanted by The responsible physician

  4. Storage and Expiration date

    Store at room temperature (1-30 ºC)

  5. Precautions

    1) This product can only be implanted in one patient with a single manufacturing lot number. Any remaining tissue after implantation must not be stored or reused and must be used as a single-use product only.
    2) This product is intended for use by a licensed clinician within an appropriate medical facility and in accordance with applicable laws and regulations.
    3) The responsible physician must notify the distributing tissue bank and return or self-dispose any tissues unsuitable for implantation, unused after opening, broken, opened, or past the expiration date.
    4) The responsible physician must notify the distributing tissue bank and return or self-dispose any tissues unsuitable for implantation, unused after opening, broken, opened, or past the expiration date.
    5) This product is a sterile product and must not be re-sterilized.
    6) Do not implant if the implantation site is infected.
    7) This product should be used individually and should be used immediately after opening.

Manufacturer

Tissue bank, MedPark| #904, #913, #916, #1007, #1008, #1009, #1010, 13-gil 25, Seonyuro, Yeongdeungpo-gu, Seoul, Republic of Korea.|TEL : 82 2 2257 8330

Sepcifications