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The AESCULAP Aicon® Container is a reusable rigid sterilization container intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed device and also maintain sterility of the enclosed device during transport and until used. This container is compatible for use in the following sterilization modalities in the configurations listed below: - Ethylene Oxide (EtO) - STERIS V-PRO maX/maX 2: Lumen, Non-Lumen, Flex - STERIS V-PRO 60: Lumen, Non- Lumen, Flex - STERIS V-PRO S2 Non-Lumen - STERRAD 100NX: Standard, Express, Flex, Duo - STERRAD NX: Standard, Advanced - STERRAD 100S - STERIZONE VP4 - PreVac Steam The AESCULAP Aicon® consists of two different container styles: a solid bottom container and enhance drying system (EDS) container. The AESCULAP Aicon® Container is compatible with accessories such as baskets, trays, instrument organizational accessories, holders, indicator cards, tamper evident locks, lid covers, faceplate holders, and tags. Prevac cycles without dry times are Immediate Use Sterilization Cycles (IUSS).

The AESCULAP Aicon® Container System is a reusable rigid container system used for the packaging, transportation, and storage of instruments prior to, during, and after sterilization. It consists of the various sizes of container bottoms, container lid, and basket options, and should only be used with designated Aesculap® filters, locks and indicator cards identified in this IFU. The AESCULAP Aicon® Container System is provided non-sterile and will undergo sterilization by the end user. The AESCULAP Aicon® Container System can be identified by its JJ Series part number. - The first digit of the model number designates the container length. - The second digit designates the height. - The last digit identifies the model and features. - Standard solid bottom container, designated by the "0" at the end of the product number. - Enhanced Drying System (EDS) solid bottom container, designated by the "1" at the end of the product number. The EDS container can also be identified by the Enhanced Drying Module, item 14 in the Product Component Diagram. The JJ Series uses the same lids for the Standard and the EDS container bottoms. Container Size | Standard Container | EDS Container | Lid ---|---|---|--- Full Size 4" | JJ110 | JJ111 | JJ410 Full Size 6" | JJ120 | JJ121 | Full Size 8" | JJ130 | JJ131 | Full Size 10" | JJ140 | JJ141 | Three-Quarter Size 4" | JJ310 | JJ311 | JJ430 Three-Quarter Size 6" | JJ320 | JJ321 | Three-Quarter Size 8" | JJ330 | JJ331 | Three-Quarter Size 10" | JJ340 | JJ341 | Half Size 4" | JJ210 | JJ211 | JJ420 Half Size 6" | JJ220 | JJ221 | Half Size 8" | JJ230 | JJ231 | Half Size 10" | JJ240 | JJ241 | The AESCULAP Aicon® Container System lid latches should remain in the closed position at all times except when installing on and removing the lid from the container bottom. The JJ Series can be used with the perforated baskets and trays of both the AESCULAP Aicon® Container System and Aesculap® SterilContainer™ System. Non-Aesculap® pre-configured baskets that meet the clearance requirements, and can be properly aseptically presented may also be used. Medical device and container IFUs parameters (time and temperature) should be reconciled. Steam sterilization dry time performance may vary by facility based on water and steam quality and/or sterilization performance. Ensure you can achieve the same end result as identified in the instrument IFU. Follow facilities policies and procedures. Notes: - Thoroughly clean all Aesculap® container products, baskets, accessories and replacement parts prior to first use and after container repair service has been performed. - Aesculap® baskets and accessories can be cleaned and sterilized following accepted industry guidelines and by using the same processes as Aesculap® sterile container bottoms. - AESCULAP Aicon® Container System has ONLY been validated with Aesculap® filters, locks and indicator cards. - Aesculap® only performed container testing with baskets and does not recommend using containers without baskets or with only mats.

The XABO Catheters are used for cerebrospinal fluid (CSF) shunting.

The XABO Catheters are manufactured using barium sulfate fillcone elastomer and are impregnated with clindamycin hydrochloride and rifampicin designed to be released over time from the exterior and inner lumen surface once implanted. The XABO Ventricular Catheters will be offered in 18 cm in length with an inner diameter of 1.2 mm and an outer diameter of 2.5 mm. Lengths are marked in 1 cm intervals starting from the catheter tip, thus enabling the surgeon to qauge the depth of penetration of the catheter into the lateral ventricle. The proximal end of the catheter has 16 flow holes around the catheter circumference. Components supplied with the XABO Ventricular Catheter include a pre-loaded stainless steel stylet and depending on the confiquration may contain a deflector. The XABO Peritoneal Catheters measure 60 cm or 120 cm in length, 1.2 mm in inner diameter, and 2.5 mm in outer diameter. There are no length markers or wall slits on the tip is open ended. The catheter may be trimmed to the proper length. The XABO Catheters are designed to articulate with existing Miethke Shunt Systems, such as the M.blue Adjustable Shunt System. Miethke Shunt System GAV 2.0 and SA 2.0 Valves, proGAV 2.0 Adjustable Shunt System miniNAV valve, and the Miethke Shunt System (DSV, connectors, and reservoirs) cleared by FDA (K192266/K190174/K161853/K141687/K110206/K030698/K011030).

The SQ.line KERRISONS (bone punches) are manually operated instruments indicated for cutting or biting bone during surgery involving the skull or spinal column.

The SQ.line KERRISON bone punches are reusable surgical instruments made out of stainless are coated with Medthin™ 42 DLC. The bone punches are available with the following features: shaft lengths 180 - 280 mm, bite sizes 1 - 6 mm, jaw openings 10 - 15 mm, cutting angles 90° and 130° up/down, standard and thin profile footplates and semi-detachable or fully detachable with an ejector.

The AESCULAP Aicon™ Container is a reusable rigid sterilization container intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed device and also maintain sterility of the enclosed device during transport and until used. This container is compatible for use in the following sterilization modalities in the configurations listed below: - Ethylene Oxide (EtO) - STERIS V-PRO maX/maX 2: Lumen, Non-Lumen, Flex - STERIS V-PRO 60: Lumen, Non- Lumen, Flex - STERRAD 100NX: Standard, Express, Flex, Duo - STERRAD NX: Standard, Advanced - STERRAD 100S - STERIZONE VP4 - PreVac Steam The AESCULAP Aicon™ consists of two different container styles: a solid bottom container and enhanced drying system (EDS) container.

The AESCULAP Aicon Container is a reusable container system intended for sterilization and storage of other medical devices. This container system is compatible for use in the following sterilization modalities: - Ethylene Oxide - STERIS VPRO maX/ maX 2: Lumen, Non- Lumen, Flex, - STERIS VPRO 60: Lumen, Non-Lumen, Flex - STERRAD 100NX: Standard, Express, Flex, Duo - STERRAD NX: Standard, Advanced - STERRAD 100S - STERIZONE VP4 - PreVac Steam The containers are perforated and made from anodized aluminum and utilize a single-use filter.

The ELAN 4 Electro Motor System is intended for high speed cutting, sawing, and drilling of bone in the fields of Spine, ENT, Neuro, and Maxillofacial Surgery.

The ELAN 4 Software V3.00, Wireless Foot Control, Drill and Attachments are designed for use with the ELAN 4 Electro Motor System (K152960). The ELAN 4 Electro Motor System is an electrical motor system consisting of a control unit with different sizes and types of hand-pieces, each containing its own integrated motor, and attachments such as burrs, saw blades, drills, etc. The Control Unit of the ELAN 4 Electro Motor System houses the system software. The ELAN 4 Software V3.00 provides support for the ELAN 4 Wireless Foot Control and ELAN 4 Drill. The ELAN 4 drill is a pistol type hand-piece designed specifically to accept various ELAN 4 attachments.

Caiman Seal and Cut Technology System consists of dedicated bipolar electrosurgical instruments intended for use in general surgery and gynecologic surgical procedures where ligation and division of vessels is desired. The instruments create a seal by the application of bipolar electrosurgical RF energy (coagulation) to vascular structure (vessels) interposed between the jaws of the device. A cutting blade is actuated for the division of tissue. Instruments 36cm and 44cm in length are indicated for laparoscopic procedures and instruments 24 cm in length are indicated for open procedures. The indications for use include general surgical procedures, (including urologic, vascular, thoracic, and thoracoscopic), and gynecological procedures where ligation and division of vessels is performed. These procedures include: vaginal hysterectomies, Nissen fundoplication, colectomy, adhesiolysis, bowel resection, and oophorectomy etc., or any procedure where vessel ligation (seal and cut), tissue grasping, and dissection is performed. The devices can be used on vessels up to and including 7mm and bundles as large as will fit in the jaws of the instrument. Caiman Seal and Cut Technology System has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the system for these procedures.

The Aesculap® Caiman Seal and Cut Technology System consists of sterile, single-use bipolar instruments that connect to a dedicated bipolar RF generator. The Caiman instruments are designed to grasp, seal (ligate), and mechanically divide (cut) varying lengths of tissue (for example mesentery) per device application. This is accomplished by a two electrode (side by side-top and bottom) design. The instruments are capable of vessel sealing, grasping, and dividing tissue enclosed within its dissection clips. The reason for this submission is to capture modifications to the caiman 12 (24cm and 44cm) instruments.

Caiman Seal and Cut Technology System consists of dedicated bipolar electrosurgical instruments intended for use in general surgery and gynecologic surgical procedures where ligation of vessels is desired. The instruments create a seal by the application of bipolar electrosurgical RF energy (coagulation) to vascular structure (vessels) interposed between the jaws of the device. A cutting blade is actuated for the division of tissue. The Caiman 12 Plus (44cm) and the Caiman 5 (36cm and 44cm) are indicated for laparoscopic procedures and the Caiman 12 Plus (24cm) and the Caiman 5 (24cm) are indicated for open procedures. The indications for use include general surgical procedures, (including urologic, vascular, thoracoscopic), and gynecological procedures where ligation and division of vessels is performed. These procedures include: vaginal hysterectomies, Nissen fundoplication, colectory, adhesiolysis, bowel resection, and oophorectorny etc., or any procedure where vessel ligation (seal and cut), tissue grasping, and dissection is performed. The devices can be used on vessels up to and including 7mm and bundles as large as will fit in the jaws of the instrument. Caiman Seal and Cut Technology System has not been shown to be effective for tubal coagulation for sterilization procedures. Do not use the system for these procedures.

The Aesculap® Caiman Seal and Cut Technology System consists of sterile, single-use bipolar instruments that connect to a dedicated bipolar RF generator. The Caiman instruments are designed to grasp, seal (ligate), and mechanically divide (cut) varying lengths of tissue (for example mesentery) per device application. This is accomplished by a two electrode (side by side-top and bottom) design. The instruments are capable of vessel sealing, blunt dissection, grasping, and dividing tissue enclosed within its dissection clips. This reason for this submission is to capture modifications to the caiman blunt instruments.

The PAS-Port Proximal Anastomosis System is intended to create the aortic anastomosis of aortic autologous vein grafts.

The Aesculap® PAS-Port Proximal Anastomosis System is a mechanical device used to facilitate an aortic vein graft anastomosis. The connector replaces sutures to create a secure, patent, and reproducible anastomosis. The PAS-Port system consists of a connector and a delivery system and is contained in a package that is designed to facilitate attachment of the conduit to the implant, as well as to ensure that the venous conduit (after attachment to the system and before deployment) is kept moist and vital.

The Miethke proGAV Programmable Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum. The Miethke proGAV 2.0 Adjustable Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum. The Miethke proSA Adjustable Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum.

The proGAV is a "programmable" shunt that can be set for a range of pressures. The valve in the proGAV is a leaf spring and ball mechanism that is mechanically controlled by internal magnets. The outer case for the device is made of titanium. The shunt comes with a manual device to verify the pressure setting and another to set or re-set the pressure. These manual accessories are both for external use by the physician. Various Miethke shunt system accessories such as shunt assistants, catheters, connectors, deflectors and reservoirs are also offered with the proGAV. proGAV 2.0 is an adjustable differential pressure valve that can be set for a range of pressures. The proGAV 2.0 valve is comprised of a titanium housing that contains a leaf spring and ball mechanism that is mechanically controlled by internal magnets. Manual devices are available to locate, verify the pressure setting and to set or re-set the pressure pre and postoperatively. These manual accessories are for external use by the physician. The device will be distributed by itself or in combination with the ShuntAssistant valve or proSA valve. The proGAV 2.0 adjustable differential pressure valve includes the same legally marketed accessories that are available with the Miethke Shunt Systems. proSA is an adjustable gravitational valve that can be set for a range of pressures. The proSA valve is comprised of a titanium housing that contains a tantalum weight, leaf spring and ball mechanism that is mechanically controlled by internal magnets. Several manual devices are available to verify the pressure setting and to set or re-set the pressure pre and postoperatively. These manual accessories are for external use by the physician. The device will be distributed by itself or in combination with the miniNAV valve or proGAV valve. The proSA adjustable gravitational valve includes the same legally marketed accessories that are available with the Miethke Shunt Systems.