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This device is a protective finger guard accessory to the surgeon's glove. (a) intended to provide needlestick and suture/scalpel protection during a variety of surgical procedures. It is a protective finger guard accessory to the surgeon's glove. It is used on the finger or thumb of the non-dominant hand usually used to retract, stabilize, compress, and position tissue during surgical procedures. (b) Facilitate suture handling and placement.

This device is a sterile single use protective finger guard worn in conjunction with surgeon's glove.

This device is made out of silicone, and it is a removable structure placed in the vagina to support the pelvic organs and is used to treat conditions such as uterine prolapse (falling down of uterus), uterine retroposition (backward displacement), or gynecologic hernia. It is available with different sizes of the following models: CUBE (with and without drain), OVAL. (with and without support), HODGE (with and without support), SHAATZ , GELLHORN (with and without drains), RING (with and without support), DONUT , GEHRUNG, DISH (with and without support), & MAR-LAND (with and without support). CUBE: indicated for use for the support of a third-degree prolapse. OVAL: indicated for use for the support of a first or mild second-degree prolapse. HODGE: indicated for use for the support of a uterine retroversion. SHAATZ; indicated for use for the support of a first or mild second-degree prolapse. GELLHORN: indicated for use for the support of a third-degree prolapse or procidentia. RING: indicated for use for the support of a first or mild second-degree prolapse. DONUT: indicated for use for the support of a third-degree prolapse. GEHRUNG: indicated for use for the support of cystocele or rectocele. DISH: indicated for use for the control of stress urinary incontinence or a first or mild seconddegree prolapse. It restores continence by applying gentle pressure to the urethra. MAR-LAND: indicated for use for the control of stress urinary incontinence or a first or mild second-degree prolapse. It restores continence by applying gentle pressure to the urethra.

This device is made out of silicone, and it is a removable structure placed in the vagina to support the pelvic organs and is used to treat conditions such as uterine prolapse (falling down of uterus), uterine retroposition (backward displacement), or gynecologic hernia. It is available with different sizes of the following models: CUBE (with and without drain), OVAL (with and without support). HODGE (with and without support), SHAATZ , GELLHORN (with and without drains), RING (with and without support), DONUT , GEHRUNG, DISH (with and without support), & MAR-LAND (with and without support). All models with their dimensions are detailed within the labeling section of this submission.

THE DEVICE IS INDICATED FR USE To Rt MATERIAL THE UTERUS 1010 UTERUS By SCRAPING / / N THE AND SUCTION IN ORDER TO OBTAIN નિર રે. 151-624 LOGICAL MENSTRALAL of for EXTRACTIO

The ETO sterilized MAS w/ Syringe is used to obtain a sample of differential endometrial tissue. The MAS w/ syringe is a 3mm (O.D.) endometrial suction device that has a Randall-like cutting edge at its distal end and is packaged with a twist-and-lock syringe. The syringe will provide a vacuum or suction during the procedure. The MAS w/ syringe is sterile unless the package is opened or damaged and designed for single patient use only. The ETO sterilized MAS without syringe is used to obtain a sample of differential endometrial tissue. The MAS is a m 3.5mm (O.D.) endometrial suction curette that has a fenestration on the wall at its distal end and a tight fitting piston that will provide a vacuum or suction during the procedure as it is pulled proximally. The MAS is sterile unless the package is opened or damaged and designed for single patient use only.

THE HEMORRHAGE OCCLUDER PIN IS INDICATED TO BE USED TO STOP MASSIVE PRESACRAL HEMORRHAGE DURING SURGERY

HEMORRHAGE OCCLUDER PIN (HOP) is of 7mm length and 8mm pinhead. It is made out of medical grade Titanium suitable for implantation.