SUTUREGARD®

Intraoperative Skin Relaxation Device

SUTUREGARD® Intraoperative skin relaxation device is comprised of two components: (1) a sterile deformable suture bridge with soft elastomer covering and (2) a sterile circular suture guide with central aperture to collect suture ends.

 

The SUTUREGARD® Intraoperative Skin Relaxation Device is indicated for intraoperative support and/or skin stress-relaxation of non-contaminated, acute surgical wounds of LESS THAN 3.0 cm width.

 

POSSIBLE ADVERSE EFFECTS

While the device has been designed to absorb the force of a high-tension suture, excessive force applied for prolonged durations may lead to pressure injury.  Pressure injury may involve damage to the epidermis, dermis, fat or underlying structures such as nerve, muscle or bone.

WARNINGS

(i) Do not reuse. This product is intended for single use, one patient only. The reuse of single-use devices can cause cross contamination and affect the device safety, performance and effectiveness, exposing patients and staff to unnecessary risk. (ii) Do not re-sterilize the bridge or suture guide. (iii) Discard open, unused devices. (iv) Do not use if package is open, torn or damaged.

 

PRECAUTIONS

Excessive force applied for prolonged durations may lead to pressure injury. The amount of force and duration of application that are tolerable will vary with patients and wound location. If the method is used beyond a given wound’s tolerability of pressure and/or duration, pressure injury may result.  For those reasons, we recommend minimizing the duration and tension as much as possible. In clinical trials, most stress-relaxation occurs within the first 30 minutes of application.

 

SUTUREGARD®

Intraoperative Skin Relaxation Device

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Copyright © 2019, DemeTECH Corporation

CONTACT US

 

DemeTECH®Corporation

14175 NW 60th Ave, Miami Lakes,

FL 33014, United States of America

+1 ( 305 ) 824  1048

+1 ( 305 ) 437  7607

info@demetech.us

TM

Intraoperative Skin Relaxation Device
Intraoperative Skin Relaxation Device
Intraoperative Skin Relaxation Device
Intraoperative Skin Relaxation Device
Intraoperative Skin Relaxation Device
Intraoperative Skin Relaxation Device
Intraoperative Skin Relaxation Device

SUTUREGARD® Intraoperative skin relaxation device is comprised of two components: (1) a sterile deformable suture bridge with soft elastomer covering and (2) a sterile circular suture guide with central aperture to collect suture ends.

 

The SUTUREGARD® Intraoperative Skin Relaxation Device is indicated for intraoperative support and/or skin stress-relaxation of non-contaminated, acute surgical wounds of LESS THAN 3.0 cm width.

 

POSSIBLE ADVERSE EFFECTS

While the device has been designed to absorb the force of a high-tension suture, excessive force applied for prolonged durations may lead to pressure injury.  Pressure injury may involve damage to the epidermis, dermis, fat or underlying structures such as nerve, muscle or bone.

WARNINGS

(i) Do not reuse. This product is intended for single use, one patient only. The reuse of single-use devices can cause cross contamination and affect the device safety, performance and effectiveness, exposing patients and staff to unnecessary risk. (ii) Do not re-sterilize the bridge or suture guide. (iii) Discard open, unused devices. (iv) Do not use if package is open, torn or damaged.

PRECAUTIONS

Excessive force applied for prolonged durations may lead to pressure injury. The amount of force and duration of application that are tolerable will vary with patients and wound location. If the method is used beyond a given wound’s tolerability of pressure and/or duration, pressure injury may result.  For those reasons, we recommend minimizing the duration and tension as much as possible. In clinical trials, most stress-relaxation occurs within the first 30 minutes of application.

Intraoperative Skin Relaxation Device