Keywords
CANCELLOUS BONE
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Keywords
골 전도성우수한 생체 적합성편리한 시술성품질 안전성
Technical Data
100% allo cancellous bone with excellent bone conductivity, a bone graft material applicable to various surgical cases
Provides a porous three-dimensional physical structure for rapid new blood vessel formation and new bone formation
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Intended Use
It is a biomaterial used for Replacement restoration reconstruction of human bone tissue.
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Preoperative Preparation
1. Aseptic techniques should be maintained to minimize the risk of developing surgical liver complications.
2. Use the appropriate amount of product depending on the patient's bone defect condition.
3. After familiarizing yourself with the instruction manual, open the outer packaging of the blister and carefully deliver the packaging inside to users wearing sterile clothing.
4. The user verifies that the inner packaging is not damaged.
5. Remove the inner wrapper and remove the syringe.
6. Turn and remove the protective cap in front of the syringe.
7. Slowly push the syringe pusher to fill the area where you want to transplant the contents.
8. Fill the bone defect with a sterile instrument.
9. After opening, it should be used only for one patient and do not reuse the remaining contents after using them once.
10. It is prohibited for use for purposes other than medical purposes and is not used except for professional medical personnel.
11. We only use products with no abnormal packaging and appearance.
12. Be sure to check if the patient is allergic to any reagents or solutions used in the treatment.
13. If the transplant site is infected, it should not be transplanted.
14. It is not used after being re-sterilized with a sterile product. -
Directions for Use
This product must be stored at room temperature (1~30℃, 34~86℉) and individually hydrated as needed.
① Open the outer packaging (Box packaging)
② Remove the PA Pouch (secondary packaging) and take out the Tyvek Pouch (primary packaging)
③ Remove Tyvek Pouch (primary packaging) and rehydrate tissue in container with sterile solution stored at room temperature
④ The tissue should use immediately after hydration where possible -
Storage and Expiration date
This product can be stored for up to 5 years in an unopened package at a dry room temp(1~30℃, 34~86℉)avoiding direct sunlight.
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Precautions
1.Do not transplant at the site where is infected or an infection is in progress. 2. According to the Human Tissue Act, the tissue transplant result record must be delivered within one month after tissue transplantation. 3. The tissue should be used immediately after rehydration if possible. 4.Disposable, do not reuse. 5.Check the sterilized packaging before use. 6.Do not use a product that expiration date has passed. 7.If contaminated products are found, discard or return them. 8. It should be used by doctors and dentists, and use other than the intended use is prohibited.
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