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The Caldera Medical BenestaTM Tissue Removal Device is intrauterine use by trained surgeons to hysteroscopically resect and remove tissue, such as: submucous myomas, endometrial polyps, and retained products of conception.

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Desara TV EZ and Desara Blue TV EZ are intended to be used in females to position a mesh for treatment of Genuine Stress Urinary Incontinence (SUI), mixed incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency. The 3.0mm or 2.7mm surgical mesh instruments are intended to be used in surgical procedures for the insertion and placement of Desara TV EZ and Desara Blue TV EZ surgical mesh indicated for treatment of Genuine Stress Urinary Incontinence (SUI), mixed incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency.

The Desara TV EZ and Desara Blue TV EZ Systems are comprised of sterile, single-use midurethral slings used to provide support in the pelvic region to treat female stress urinary or mixed incontinence and a stainless steel disposable introducer in either a 3.0mm or 2.7mm diameter. The devices are intended to be used in females, via the transvaginal surgical approach in the in-patient or out-patient clinical setting. Desara TV EZ and Desara Blue TV EZ slings are manufactured out of monofilament polypropylene yarn, which is knitted into a mesh. The devices include mesh placement aides consisting of: integral sleeves over the mesh, a removable EZ tab midline indicator and dilator tubes at each end of the device which attach to the 3.0mm or 2.7mm transvaqinal surqical introducer for placement of the mesh. All placement aids are removed after the device is positioned and only the mesh portion of the device remains as a permanent implant.

The Caldera Medical Benesta™ Tissue Removal Device is intended for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue such as: submucous myomas, endometrial polyps, and retained products of conception.

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The Benesta ™ Hysteroscope is used to permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.

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The Benesta™ Sterilization Tray is intended to enclose and protect the Caldera Medical Rod Lens Hysteroscope and accessories during sterilization and storage. The Benesta™Sterilization Tray must be used in conjunction wrap that is cleared by the FDA for the indicated sterilization cycles. STEAM STERILIZATION | | Pre-Vacuum | Gravity | |------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | Temperature | 132 °C | 132°C | | Exposure Time | 4 minutes | 15 minutes | | Dry Time | 45 minutes | 45 minutes | | Device Storage Conditions | Do not double stack, store in a cool dry location after<br>sterilization | | | Sterility using FDA validated wrap | Sterility is maintained until wrap is opened or<br>otherwise compromised | | | Validated Device Contents | ≤20 lbs. (1) Caldera Medical Rod Lens Hysteroscope<br>(1) Caldera Medical Removable Outflow Channel (2)<br>Light post adapters, (1)<br>Valve Cap (2) Valve Insert End Cap | |

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The Desara One mid-urethral mesh implant is intented for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The Desara One introducer is intended for the placement of the Desara One single incision mesh implant.

Desara® One Single Incision Sling System

The Caldera Medical surgical mesh instruments are intended to be used in surgical procedures for the insertion and placement of Desara surgical mesh indicated for treatment of Genuine Stress Urinary Incontinence (SUI) and mixed incontinence. Caldera Medical Outside-In introducers may be used with the following Desara implants: Desara® (CAL-DS01), Desara® Blue (CAL-DS01B), Desara® Blue OV (CAL-DS01BOV), Desara® SL (CAL-DS01SL), Desara® Blue SS (CAL-DS01BS) Caldera Medical Inside-Out introducers may be used with or without the Winged Guide Accessory with the following Desara implants: Desara® (CAL-DS01), Desara® Blue (CAL-DS01B), Desara® Blue OV (CAL-DS01BOV), Desara® SL (CAL-DS01SL) Caldera Medical Suprapubic introducers may be used with the following Desara implants: Desara® (CAL-DS01), Desara® Blue (CAL-DS01B), Desara® Blue OV (CAL-DS01BOV), Desara® Blue SS (CAL-DS01BS) Caldera Medical Transvaginal introducers may be used with the following Desara implants: Desara® (CAL-DS01), Desara® Blue (CAL-DS01B), Desara® Blue OV (CAL-DS01BOV) Desara® TV (CAL-DS01TV), Desara® Blue TV (CAL-DS01BTV) implants may only be used with Caldera Medical Transvaginal introducers, CAL-TV32

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Desara® TV and Desara® Blue TV are intended to be used in females to position a mesh for the treatment of Genuine Stress Urinary Incontinence (SUI), mixed incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency.

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Vertessa® Lite may be used for the repair of uterine or vaginal vault prolapse that require support material. It may be used in open or laparoscopic abdominal procedures.

Vertessa® Lite devices are designed to be used in women suffering from uterine or vaginal vault prolapse and are implanted or affixed using suture of the surgeon's choice. Vertessa® Lite devices are provided sterile and are comprised of macroporous monofilament polypropylene warp knit blue mesh. Vertessa "Lite will be available in a rectangular flat sheet mesh and rectangular strip mesh designs. The flat sheet mesh designs are available in the following sizes: 8 x 16 cm, 8 x 18 cm, 8 x 20 cm, 8 x 22 cm, 8 x 24 cm, 8 x 26 cm, 10 x 16 cm, 10 x 18 cm, 10 x 20 cm, 10 x 22 cm, 10 x 24 cm, 10 x 26 cm, and 11 x 30 cm. The strip mesh designs are available in the following sizes: 4 x 16 cm, 4 x 18 cm, 4 x 20 cm, 4 x 22 cm, 4 x 24 cm, 4 x 26 cm, 5 x 18 cm, 5 x 20 cm, 5 x 20 cm, 5 x 22 cm, 5 x 24 cm, 5 x 26 cm, and 6 x 30 cm.

Vertessa® Lite Y-Mesh may be used a bridging material for as sacrocolposuspension/sacrocolpopexy (laparotomy; laparoscopic, or robotically-assisted approach) where surgical treatment for vaginal vault prolapse is warranted.

Vertessa® Lite Y-Mesh devices are designed to be used in women suffering from uterine or vaginal vault prolapse and are implanted or affixed using suture of the surgeon's choice. Vertessa® Lite Y-Mesh devices are provided sterile and are comprised of macroporous monofilament polypropylene warp knit clear mesh. Vertessa® Lite Y-Mesh will be available in a y-shape design of five different sizes (22 x 4 x 3 cm, 22 x 4 x 4 cm, 22 x 5 x 4 cm, 26 x 4 x 3 cm, 26 x 5 x 4 cm).