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Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer is intended to be used in medical, dental, surgical, healthcare, and laboratory applications (e.g hospitals, nursing homes, surgical centers, healthcare clinics, or dental offices) to sterilize heat and moisture-stable reusable loads that are solid, hollow, porous, or delicate, in either wrapped or unwrapped arrangements.

Validated sterilization cycles of LifeUltra include:

Class B cycles

• 134 °C (273 °F) for 4 minutes sterilization with 20 minutes drying - wrapped/unwrapped instruments, hand pieces, textiles, and porous loads (max 7 kg).
• 121 °C (250 °F) for 20 minutes sterilization with 20 minutes drying - delicate or wrapped/unwrapped loads (max 7 kg).

Class S cycles

• 134 °C (273 °F) for 4 minutes sterilization with 20 minutes drying - wrapped/unwrapped instruments and hand pieces (max 7 kg).
• 121 °C (250 °F) for 20 minutes sterilization with 20 minutes drying - delicate loads (max 7 kg).

The autoclave is fully automatic (a computerized control unit ensures a fully automatic sterilization cycle, control and monitoring of physical parameters and a clear documentation of the sterilization cycle. Drying is performed with the door closed).

This autoclave uses steam as a sterilizing agent.

The autoclave is equipped with a vacuum system, which supports:

• Removal of residual air from packs and porous load and most kinds of tubes (rubber, Plastic etc.) by vacuum at the first stage of the cycle.
• Steam penetration into the load; resulting in effective sterilization.
• Temperature uniformity.
• Post sterilization drying phase

The device has a built-in thermal printer with the following feature:

• The Thermal printer can print the cycle data immediately after cycle completion.
• The print data includes Realtime values of Temperature (°C/°F) and pressure (Bar/kPa) including the overall cycle time.
• The print data also includes overall conditioning time, pressurizing time, sterilization time, and the drying time with the maximum and minimum temperature attained during the sterilization along with the Pass/Fail results.

LifeUltra™ is controlled by a micro-controller with installed software that has pre-set programs to run standard B, S sterilization cycles and test cycles. Saturated steam for sterilization is generated from distilled water, produced in an onboard water distiller, so users can directly tap into municipal facility water. For this feature, the device is programmed to run an automatic water distilling cycle and a manual tank descaling cycle. The integrated software manages the air-water-steam system through precision sensors, probes, and switches that both monitor and control the device's vital parameters in real-time, assuring safe and successful results. The operation of the device is through a back-lit display and control interface.

The door's locking mechanism is designed to allow closing/opening the door, easily, with one hand.

The chamber door has the following features protecting personnel from hazards:

• One door micro-switch indicates that the door is closed. Without this indication steam is not introduced into the chamber. An electrical door locking pin that blocks door opening during cycle operation. The micro-switch prevents opening the door while the chamber is pressurized and at the end of cycle until chamber pressure equalizes to room pressure.
• Additionally, a mechanical lock that blocks door opening at positive pressure.

In addition, the following safety devices are installed in the autoclave to optimize its safe operation:

• A safety thermostat to prevent over-heating of the chamber heating elements.
• A safety thermostat to prevent over-heating of the steam generator.
• A pressure safety valve to prevent over-pressurizing of the chamber.

There is a municipal water inflow input port for up to 500 ppm. There are 2 output ports for demineralized water tank and wastewater tank overflow/drain outlet. The chamber is made of corrosion-resistant 316L stainless steel, and the door is made up of Aluminum Hard Anodized with Teflon coating. The outer covers are made of Carbon Steel with coating.

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Hair Regrowth Cap is indicated to treat Androgenetic Alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of IIa - V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I-1 to I-4, II-1, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I - IV.

The Hair Regrowth Cap (HRC) is a wearable device designed to treat androgenetic alopecia in both men and women. The cap utilizes LED light phototherapy to stimulate hair regrowth through a daily treatment session of approximately 10 minutes.

The system consists of a soft, comfortable textile cap embedded with LEDs, powered by a rechargeable battery. It includes driver electronics and is easily operated via a built-in switch button located on the cap. Hair Regrowth Cap device cannot operate while charging. The device has no communication function.

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The Paruu Wearable Breast Pump is a powered breast pump intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user.

The Paruu Wearable Breast Pump is a powered breast pump intended to be used by lactating women to express and collect milk from their breast in home healthcare environment. The breast pump stimulates lactation and extracts milk from the breasts by creating a seal around the nipple and applying and releasing suction to the breast. The breast milk is collected in a milk collector. The device consists of a pump motor (main unit), milk collection set (flange, diaphragm, duckbill valve, milk collector, flange cover) and accessories (flange insert, charging cable). The milk collection set and flange insert can be purchased separately.

The device uses a diaphragm-type vacuum pump driven by a microprocessor. The microprocessor provides control over vacuum pressure and cycle speed. The user interface consists of buttons allowing the user to switch between modes and control the vacuum pressure levels, and LED display that providing information on current mode, level, timer and battery status.

The device includes 23 different models, and based on their technological characteristics, are divided into two broad categories – P16 series consisting of models P16, P16-A, P16-B, P16-C, P16-D, and P20 series consisting of models P20, P9, P10, P10 PRO, P21, P22, P23, P24, P25, P26, P27, P28, P29, P30, P20-A, P20-B, P20-C, P20-D. The models within each series vary in terms of their external color. All device models include 4 working modes (Stimulation, Expression, Two-in-one and Dual frequency for P16 Series and Stimulation, Expression, Lactation, and Traction for P20 Series) and 12 suction levels for each mode.

To prevent milk from flowing into the vacuum system, the milk collection set includes a diaphragm that physically separates the milk-contacting pathway from the vacuum system. The motor unit operates on 3.7V rechargeable lithium battery. The rechargeable battery can be charged from the external power adapter (not included with the device) through the provided charging cable. All milk contacting components of the device are compliant with 21 CFR 177.

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LacertaMatrix is indicated for use in the management of the following wounds:

• partial and full-thickness wounds
• pressure ulcers
• venous ulcers
• diabetic ulcers
• chronic vascular ulcers
• tunneled / undermined wounds
• surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence)
• trauma wounds (abrasions, lacerations, partial thickness burns, and skin tears)
• draining wounds

LacertaMatrix is a single use, non-pyrogenic wound dressing intended for use in local management of full thickness and partial thickness wounds. LacertaMatrix includes alligator derived hyaluronic acid (HA). LacertaMatrix is provided sterile in various size offerings up to 100cm² in a dual pouch configuration for aseptic transfer. Following placement, LacertaMatrix is gradually broken down and resorbed over time (typically over a period of within 2 weeks), as new tissue forms in its place.

This device is limited to only one-time application to the wound. This device can only be used once within 24 hours and should be completely remove by rinsing with PBS to remove any residual device. Second application is restricted. Please use other FDA cleared dressing.

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The LIA-1 Catheter is intended for use through a compatible bronchoscope in the tracheobronchial tree for Optical Coherence Tomography (OCT) guided Fine Needle Aspiration (FNA) and Fine Needle Biopsy (FNB) of endobronchial lesions, peripheral lung nodules, and lung masses. The device collects real-time two-dimensional, cross-sectional depth images which are visualized for evaluation of human tissue microstructure on the LIA Console.

Do not use this device for any purpose other than its intended use. This device is intended to provide an image of tissue microstructure in the tracheobronchial tree and parenchyma. The safety and effectiveness of this device for diagnostic analysis (i.e., differentiating normal versus specific abnormalities) in any tissue microstructure or specific disease has not been evaluated.

LIA-1 Catheter is a sterile, single-use, Optical Coherence Tomography (OCT) image-guided biopsy needle which is an assembly consisting of a Handle, Outer Sheath, Needle, and Imaging Stylet (iStylet). The Outer Sheath and Needle are attached to Actuation Handle and the iStylet is located within the Needle.

Outer Sheath: The LIA-1 Catheter Outer Sheath consists of a clear tube attached to the Handle.

Handle: The LIA-1 Catheter Handle allows the user to actuate the needle from the distal tip of the Outer Sheath, and to actuate the iStylet into or out of the Needle tip, or to be retracted for biopsy collection, as necessary.

Needle: The 21G stainless-steel Needle has a beveled, sharpened tip for puncture and tissue collection.

Imaging Stylet: The iStylet consists of a shaft and imaging core serving as an optical imaging probe. It provides real-time imaging for its intended use.

The LIA-1 Catheter is intended to be used only in conjunction with the LIA Console in order to function as intended.

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The LIA Console is indicated for use as an imaging tool in the evaluation of human tissue microstructure in the tracheobronchial tree by providing two-dimensional, cross-sectional, real-time depth visualization using Optical Coherence Tomography (OCT).

The safety and effectiveness of this device for diagnostic analysis (i.e., differentiating normal versus specific abnormalities) in any tissue microstructure or specific disease has not been evaluated.

The LIA Console is indicated for use as an imaging tool in the evaluation of human tissue microstructure in the tracheobronchial tree by providing two-dimensional, cross-sectional, real-time depth visualization using Optical Coherence Tomography (OCT).

The LIA Console is intended to be used only in conjunction with the LIA-1 Catheter in order to function as intended.

LIA Console consists of the following main parts:

1. Monitor: 24-inch multi-touch display monitor allowing software user interface.

2. Catheter Driving Unit (CDU): Electromechanical and optical interface between the LIA Console and the LIA-1 Catheter. A rotary motor inside drives the LIA-1 Catheter to form 360-degree side view real-time imaging.

3. Catheter Driving Arm (CDA): A supporting arm allowing CDU positioning, mobility and flexibility during the procedure.

4. Image Engine: The main body of the LIA Console contains laser source, computing unit, data acquisition and power distribution module and other components.

5. Caster: Four caster wheels installed at the base provide mobility for the LIA Console. Each caster is equipped with a brake that can lock the LIA Console in place as needed.

6. OCTICA Software: A proprietary GUI-based software that controls data acquisition, rotary motor and other hardware components to enable real-time OCT imaging of tissue microstructure.

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The SPINELINC Anterior Cervical Implants include cervical interbody fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) for one or two levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. The SPINELINC Cervical Spacer Body and Anterior Cervical Spaver are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. The SPINELINC Cervical Spacer Body and Anterior Cervical Spacer are intended to be used with FDA cleared supplemental fixation. Only the SPINELINC Cervical Spacer Body is compatible with the SPINELINC Plates and Screws. When used with the SPINELINC Plate and Screws, the plate-spacer assembly takes on the indications for use of the SPINELINC Cervical Spacer Body, with the SPINELINC Plate and Screws acting as the supplemental fixation. The SPINELINC Plate and Cervical Spacer Body assembly is a stand-alone device intended for use at one or two levels of the cervical spine (C2-T1) and is to be used with three SpineLinc screws per assembly.

The SpineLinc Anterior Cervical Implant system consists of a cervical interbody fusion device, cervical plate, screws, and a locking clip, which may be implanted in various configurations to accommodate patient anatomy. The SpineLinc Anterior Cervical implant devices are offered manufactured from titanium alloy per ASTM F136 or ASTM F3001. Instrumentation is provided with the SpineLinc Anterior Cervical Implant system to facilitate implantation. Instruments are manufactured from medical grade stainless steel per ASTM F899. All subject implants and instruments are provided sterile via gamma irradiation and are provided as single use kits.

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