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Dental Barrier and Sleeves are intended to be used as a disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient use only.

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The iTero Lumina Pro NRI functionality is a diagnostic aid for the detection of interproximal carious lesions above the gingiva and for monitoring the progress of such lesions.

The iTero Lumina Pro is an integrated intraoral imaging system capable of capturing 3D optical impressions for CAD/CAM of dental devices, 2D color images and Near Infrared (NIR) images. Scanning cycles are employed allowing the system to quickly alternate between the three modalities, creating a virtually simultaneous capture of the 3D optical impression, 2D color and NIR images. The iTero Lumina Pro consists of the following main components: - A. Scanning Wand used for intraoral scanning. - B. Wand Cradle used to hold the Scanning Wand when not in use. - C. Application Software that includes Graphical User Interface ("GUI"). - D. Computer platform The scanning wand houses electronic, mechanical, and optical components, including projectors, LEDs and cameras which enables capturing 3D impression data as well as 2D color and NIRI images. The wand body is made of Aluminum, Copolyester and Glass. When not in use, it is stored in the Wand Cradle. The iTero Lumina Pro features proprietary software that can be installed on the various configurations of the computer platform. The software is designed to manage the GUI, control the scanning process, display the scanned images, and connect to the stored patient data, including scanned data for display or export. The iTero Lumina scanning wand is designed to be used with a single-use, non-sterile, disposable, wand barrier sleeve. The only patient-contacting materials are those contained within the wand barrier sleeve.

Dental Barrier and Sleeves are intended to be used as a disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient use only.

Dental Barrier and Sleeves consist of various sizes and shapes of polyethylene covers which are positioned on various small hand-held dental instruments such as hand pieces, curing lights, air/water syringes and similar hand instruments. In other forms, they are used to cover various devices such as dental chairs, dental instrument trays, x-ray heads, and others. The products are sold non-sterile, prepackaged, and are disposable, single use only.

The BeneHold™ Surgical Incise Drape with CHG antimicrobial II is indicated for use as an incise drape with continuous antimicrobial activity (in vitro) from 30 minutes through 4 hours of use against the following organisms: S. aureus, S. epidermidis, E. coli, P. aeruginosa, E. aerogenes, and C. albicans. In vitro testing on the subject drape has also shown continuous antimicrobial activity from 30 minutes through 2.5 hours against E. faecalis and F. oxysporum. It is intended for external use only. Correlation between in vitro results and any clinical event has not been tested.

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SECUREPORTIV® ADVANCED Catheter Securement Adhesive is to be applied as a film forming securement and sealant at the point of vascular access catheter skin entry. The film holds the catheter to the skin to reduce catheter movement, migration, and/or dislodgment. It is used to protect the catheter skin entry site by creating a sealant that immobilizes surface bacteria, preventing them from entering into the catheter skin entry site while a moisture barrier. SECUREPORTIV® ADVANCED is intended to be used with a transparent film dressing for the securement of short-term and long-term vascular access catheters including peripheral IVs, PICCs, and CVCs.

SecurePortIV Advanced Catheter Adhesive is a sterile, professional liquid cyanoacrylatebased adhesive containing a monomeric formulation (2-octyl cyanoacrylate) and the colorant D&C Violet #2. The device is an applicator with the formulation incorporated in an ampoule housed in a tapered plastic tube. The SecurePortIV Advanced liquid is applied as a film forming securement and sealant at the point of catheter skin entry, polymerizing in minutes.

3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) is indicated for use as an incise drape with continuous antibacterial activity based on in vitro time kill data out to 90 minutes. It is intended for external use only.

3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) is a sterile adhesive film that is applied pre-operatively to skin. It adheres and conforms to body contours, providing a sterile surface on top of the skin prior to surgery. The surgeon incises through the adhesive film and skin, ensuring a sterile film barrier all the way to the edge of the incision. The Chlorhexidine Gluconate (CHG) contained in the adhesive provides antibacterial activity to help reduce the risk of bacterial contamination in the surgical wound. The drape consists of a transparent, conformable, barrier film coated with an acrylic adhesive containing 2% w/w CHG. The adhesive drape is delivered on a release liner that is discarded after application.

The L1P-1F intraoral scanner (IOS) system is intended for aid in diagnosis of caries.

The L1P-1F intraoral scanner (IOS) system is intended for aid in diagnosis of caries. The L1P-1F system consists of a scanner and a detachable scanner tip which enables scanning using white and blue (fluorescence) Light Emitting Diodes (LEDs). A single-use scanner body sleeve is mounted on the scanner before being introduced into the mouth of a patient for scanning of the teeth. The interface to the computer is handled by ScanSuite TRIOS which functions as a Hardware Abstraction Layer (HAL). The scan control of, and information from the scanner is handled by the TRIOS module software, which holds the interface to the user. The L1P-1F system also consists of the TRIOS Patient Monitoring software which aids in diagnosis of occlusal and surface caries. The functional principle of L1P-1F (TRIOS 5) is to collect images of the object scanned by means of focus scanning, where light from the LEDs travels through the optical system to the object being scanned and back to an image sensor. 3D true colored images of the teeth combined with 2D green and red image as an additional texture are generated by emitting blue and white light in turn.

The Medline General Surgery Tray contains a single-use sterile surgical drape intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The drape is packaged and sterilized with disposable devices intended for professional use/used by licensed physicians in preparing the operating environment for, and performing procedures and surgeries. The intended products assembled in these kits will not be changed from the manufacturer's original intended use.

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