Silkpdo warranty

Polydioxanone Absorbable Monofilament Suture with Barbs

Description

The SILK PDO consists of barbed suture material and is dyed (violet) polyester, poly(p-dioxanone). The pigment for the violet dye is D&C Violet No.2.

1) Trade name : SILK PDO

INDICATIONS FOR USE

SILK PDO is indicated for use in soft tissue approximation where use of an absorbable suture is appropriate

PREPARATIONS BEFORE USE

1)Check the damage of sterile packaging and whether or not it is contaminated and use period.

2) Be careful to avoid contamination under sterile environment

3) It shall be determined by the doctor for surgical methods and techniques.

4) Use a suitable number depending on the size and shape of the affected part in accordance with the procedure.

5)

PRECAUTIONS

1) It should be used by healthcare professionals, and prohibit the use except intended use.

2) Before surgery, health care professionals should be well aware of use procedures and treatment procedures for the product.

3) Without special prescription from your doctor, it should not be used to treat bacterial infection around the area where the infection is in progress.

4) Prior to use, confirm whether the product is damaged or not. And the product should not be used if damage is checked.

5) It should be used immediately after removing the product from sterile packaging.

6) It should be used in the room temperature environment instead of the freezing or heat treatment

7) It does not reuse because of disposable product

8) Use after confirmation of sterilized packaging.

9) Products broken or damaged in packaging are not used.

10) Products whose valid period has elapsed will not be used.

11) Be careful not to contaminate the product and discard or return If a contaminated product is found.

12) Once sterilized products should not be re-sterilized to use

13) User should be familiar with the surgical procedures and techniques related to the absorbable suture prior to use in wound closure

WARNING

1) Do not reuse it because of disposable medical devices.

2) Do not use the product of broken or damaged packaging..

3) Because this is an absorbable suture, surgeons should consider whether non-absorbable sutures are used for additional support or not. for closure of organization being enlarged or stretched or distended or the site of additional support needed.

4) For fascial closure (abdominal, thoracic, including closed end fascia), stomach connecting, cardiovascular tissue, nerve tissue, ophthalmic surgery, microsurgery, its safety and effectiveness have not been established. Under certain circumstances, it may be fixed by utilizing the well-known orthopedic procedures and outside support to the discretion of the surgeon.

5) As absorbable suture, it can act as a foreign substance temporarily.

6) For contaminated or infected wounds, the measures must be in accordance with acceptable surgical practice.

CONTRAINDICATIONS

1) It may be inappropriate to old men, nutritional status defaulters, debilitating patients or patients suffering from conditions that can be delayed.

2) It should be used carefully for people with chronic conditions such as diabetes, heart or lung disease, circulatory disease and obesity.

3) It should not be used if there is a possibility that a patient may cause side effects. Patients with decreased immunity should be paid to particular attention.

4) The part that has a long-term pressure on the joint organization (more than 6 weeks) is not used. Prosthetic device that is not characteristic absorption is not used for a fixing of prosthetic devices (eg, heart valves, or artificial transplants)

ADVERSE REACTIONS

1) Likewise other foreign substances, if the suture is contacted in long term in salt solution such as those found in the urinary tract or the bile system, stone may be formed.

HOW SUPPLIEd

1) Surgical sutures are sterile.

STORAGE CONDITIOn

1~25℃, below 60%RH

DISPOSAL REQUIREMENTS

After using, it must be properly disposed of in compliance with local or hospital regulations that it is appropriately packaged and secured.

EXPIRATION DATE

1 Years from manufacturing

USP COMPLIANCE STATEMENT:

This medical device product SILK PDO (Absorbable Polydioxanone Surgical Suture) has met all relevant USP requirement performance specifications relating to surgical sutures.

WARRANTY, LIMITATION OF LIABILITY AND DISCLAIMER OF OTHER WARRANTIES

ACTIVE MEDICAL TECHNOLOGY or HYME HOLDINGS? , excludes all warranties, whether expressed or implied by law or otherwise, including but not limited to, any implied warranties of merchantability of fitness of use. ACTIVE MEDICAL TECHNOLOGY or HYME HOLDINGS ? , shall be replacement of the product.

HYME HOLDINGS

90, Opaesan-ro, Seongbuk-gu, Seoul. 116-801. Republic of Korea.

Silkpdo warranty

Polydioxanone Absorbable Monofilament Suture with Barbs

Description

The SILK PDO consists of barbed suture material and is dyed (violet) polyester, poly(p-dioxanone). The pigment for the violet dye is D&C Violet No.2.

1) Trade name : SILK PDO

INDICATIONS FOR USE

SILK PDO is indicated for use in soft tissue approximation where use of an absorbable suture is appropriate

PREPARATIONS BEFORE USE

1)Check the damage of sterile packaging and whether or not it is contaminated and use period.

2) Be careful to avoid contamination under sterile environment

3) It shall be determined by the doctor for surgical methods and techniques.

4) Use a suitable number depending on the size and shape of the affected part in accordance with the procedure.

5)

PRECAUTIONS

1) It should be used by healthcare professionals, and prohibit the use except intended use.

2) Before surgery, health care professionals should be well aware of use procedures and treatment procedures for the product.

3) Without special prescription from your doctor, it should not be used to treat bacterial infection around the area where the infection is in progress.

4) Prior to use, confirm whether the product is damaged or not. And the product should not be used if damage is checked.

5) It should be used immediately after removing the product from sterile packaging.

6) It should be used in the room temperature environment instead of the freezing or heat treatment

7) It does not reuse because of disposable product

8) Use after confirmation of sterilized packaging.

9) Products broken or damaged in packaging are not used.

10) Products whose valid period has elapsed will not be used.

11) Be careful not to contaminate the product and discard or return If a contaminated product is found.

12) Once sterilized products should not be re-sterilized to use

13) User should be familiar with the surgical procedures and techniques related to the absorbable suture prior to use in wound closure

WARNING

1) Do not reuse it because of disposable medical devices.

2) Do not use the product of broken or damaged packaging..

3) Because this is an absorbable suture, surgeons should consider whether non-absorbable sutures are used for additional support or not. for closure of organization being enlarged or stretched or distended or the site of additional support needed.

5) As absorbable suture, it can act as a foreign substance temporarily.

6) For contaminated or infected wounds, the measures must be in accordance with acceptable surgical practice.

CONTRAINDICATIONS

1) It may be inappropriate to old men, nutritional status defaulters, debilitating patients or patients suffering from conditions that can be delayed.

2) It should be used carefully for people with chronic conditions such as diabetes, heart or lung disease, circulatory disease and obesity.

3) It should not be used if there is a possibility that a patient may cause side effects. Patients with decreased immunity should be paid to particular attention.

4) The part that has a long-term pressure on the joint organization (more than 6 weeks) is not used. Prosthetic device that is not characteristic absorption is not used for a fixing of prosthetic devices (eg, heart valves, or artificial transplants)

ADVERSE REACTIONS

1) Likewise other foreign substances, if the suture is contacted in long term in salt solution such as those found in the urinary tract or the bile system, stone may be formed.

HOW SUPPLIEd

1) Surgical sutures are sterile.

STORAGE CONDITIOn

1~25℃, below 60%RH

DISPOSAL REQUIREMENTS

After using, it must be properly disposed of in compliance with local or hospital regulations that it is appropriately packaged and secured.

EXPIRATION DATE

1 Years from manufacturing

USP COMPLIANCE STATEMENT:

This medical device product SILK PDO (Absorbable Polydioxanone Surgical Suture) has met all relevant USP requirement performance specifications relating to surgical sutures.

WARRANTY, LIMITATION OF LIABILITY AND DISCLAIMER OF OTHER WARRANTIES

ACTIVE MEDICAL TECHNOLOGY or HYME HOLDINGS? , excludes all warranties, whether expressed or implied by law or otherwise, including but not limited to, any implied warranties of merchantability of fitness of use. ACTIVE MEDICAL TECHNOLOGY or HYME HOLDINGS ? , shall be replacement of the product.

HYME HOLDINGS

90, Opaesan-ro, Seongbuk-gu, Seoul. 116-801. Republic of Korea.