Search Results

The ALATUS Vaginal Balloon Packing System is a single use, non-sterile, disposable, flexible, inflatable, non-powered positioning device, intended to be used on a daily treatment basis for the temporary positioning of the vaginal wall and adjacent structural anatomies. The purpose of the device is to displace and stabilize the vaginal wall during computed tomography (CT) exam, x-ray, or radiation treatment (RT) therapy. The placement of the balloon requires a physician or physician directed healthcare professional, and it is performed as a separate procedure outside of the standard (CT) exam and (RT) treatment. This device is not intended to be inserted into the uterine cavity.

The ALATUS Vaginal Balloon Packing System is designed as an immobilizer to assist in positioning and displacing the vaginal wall in a more predictable and reproducible location during computed tomography (CT) exams and radiation treatment (RT) therapy. The proposed device is a latex free balloon made from Polyurethane consisting of the following components: 1. Balloon 2. Catheter tubing 3. Connector 4. Flex tubing 5. 1-way stopcock, 90° turn handle

InsertEase™ is to be used as a device for the insertion of prescription and over the counter suppositories into the rectum

The rectal suppository applicator, to be called, InsertEase™, is a plastic, non sterile, single use device for the insertion of prescription and over the counter suppositories into the rectum. The design of InsertEase™ is substantially equivalent to a vaginal applicator used for inserting vaginal suppositories, creams and tampons. One piece, the plunger, will be movably coupled within a second piece, the barrel. The barrel has an open end to receive and hold a suppository, which is then inserted into the anus. The plunger is then pushed into the barrel and places the suppository within the rectum. InsertEase™ functions in the same way and manner that vaginal applicators insert vaginal suppositories and tampons.

The Alexis Wound Retractor (large and extra large size only) is indicated for use to provide abdominal access during routine non-urgent cesarean deliveries. The Alexis Wound Retractor was previously cleared for the following general indications for use (K041711) : - l Access the abdominal cavity during surgery through an atraumatically retracted incision. - 피 Delivery maximum exposure of the abdominal cavity with minimum incision size. - 트 Protect against wound contamination during laparoscopic and open surgery. - . Seal off the incision opening to permit insufflating the peritoneum. - 트 Convert the incision wound to an additional trocar port site. - 트 Access the thoracic cavity or other soft tissue retraction during cardiac and general surgical procedures through an atraumatically-retracted incision.

The Applied Wound Retractor consists of a flexible polymer membrane formed into the shape of a cylinder. Attached to each open end of the cylinder are two semi-rigid polymer rings. To perform these functions, Alexis Wound Retractors are constructed as a cylindrical membrane sheath that has two rings attached to each open end. The rings are molded in a plastic material The Wound Retractor package also includes an incision template. The Wound Retractor is simple to set up and easy to use. A sterile skin marker is used to mark an incision line at the surgery site and the incision is made. The Wound Protecting theath is placed in position through the incision with one ring inside the abdomen. The external ing is placed in traction and folded over itself until it contacts the abdomen. Once securely in place, the Alexis Wound Refractor keeps the incision open during the procedure. The wound protective sheath lines the incision and protects against wound contamination during the procedure. The Applied Wound Retractor is a disposable, single-use device and is packaged inside a Tyvek/Mylar peel pouch, which is standard packaging material for Applied's products. The packaged product is then placed in an outer product shelf pack.

EpiStat is intended for use by physicians and trained obstetrics/gynecology nurse practitioners during episiotomy repair procedures. EpiStat is intended to temporarily tamponade the post partum discharge of fluids from the vagina in order to assist with the episiotomy repair procedure. V-Stat is intended for use by physicians for temporary haemostatic control following vaginal surgery procedures such as (a) post operative packing for posterior and anterior vaginal repairs (b) brisk introperative bleeding during urethral sling procedures and post operative packing to control sub-pubic haematoma following urethral sling procedures.

EpiStat is an inflatable balloon tamponade device designed to provide a safe and effective method of temporarily tamponading the vagina to assist with post partum episiotomy repair. EpiStat is provided sterile in peel-open packages and intended for onetime use. V-Stat is an inflatable balloon tamponade device designed to provide a safe and effective method of achieving haemostatic control by direct or indirect compression of vaginal tissues as a result of the inflation of a balloon using air. V-Stat is provided sterile in peelopen packages and intended for one-time use.

The Apple Medical OB/Mobius Elastic Retractor is indicated for use to assist in nonurgent cesarean deliveries that are routine procedures. It is intended to provide incision retraction and to protect against wound contamination during a cesarean section. It is indicated for use as a surgical retractor for both vertical and transverse incisions.

The Apple Medical OB/Mobius® Elastic Retractor is a sterile disposable abdominal retractor consisting of two flexible plastic rings connected by a sleeve of soft, high yield strength, clear plastic film. The internal ring has a circular cross-section (o-ring) and the external ring has a cruciform cross-section (quad-ring). The inner diameter of the internal o-ring limits the radius of abdominal retraction. The diameter of the external quad-ring is the same as the diameter of the internal o-ring and the sleeve. When completely unwound, the height of the cylinder is 10.6 inches. When the quad ring is rolled down, the sleeve is wrapped around the circumference of the ring reducing the height of the sleeve by 1.5 inches per rotation. Because the sleeve film is radially unyielding, the reduction in height causes the radial retraction of the incision site.

Not Found

Circumcision Clamp