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The Helix system consists of:
• Laser system console (containing the optical bench assembly and laser, the microcontroller control electronics and system software, the high voltage power supply, the laser cooling system, the compressed air-purge system, and the service panel)
• LCD control panel with touch-screen technology: the LCD display provides information on the status and settings of the Helix system with touch-screen technology provided to input commands into the system.
• Two wavelengths – CO2 and 1570 nm
• Articulated arm
• Footswitch
• Delivery devices (CO2 non-fractional applicators, Scanner CO2/1570nm fractional applicator)
EL.EN. SPA
M133A1
In Commercial Distribution
- 08057017760665 ()
M133A1
- General/multiple surgical diode/carbon dioxide laser system
The Dental High-speed Turbine Handpiece is the dental clinic, hospital treatment for patients with tooth disease tools, which is an effective instrument for drilling, grinding, repairing. It composed of handpiece and a connector.
The handle is slide-proof, comfortable and easy to clean. Handpiece and adaptors can bear steam disinfection at 135°C. The head angle can provide better operational vision and angle so that work efficiency can be improved. Cartridges have high precision when rotating; cartridges have low noise and high efficiency. The scope of application: for dental professional use only.
Lubricant should be used during routine maintenance (e.g. after each patient use and prior to sterilization).
In order to avoid the risk, user must buy and use specified lubricant type “PANA SPRAY Plus” manufactured by NAKANISHI INC (cleared in K163483).
Guangdong JINME Medical Technology Co., Ltd.
T, S, TU, SU, TP, SP, TUQ, TUP, SUP, SUQ, TUQP, SUQP
In Commercial Distribution
- 06971119540012 ()
- Dental power tool system handpiece, pneumatic
- The EP-8000 is an endoscopic processor with an integrated light source that is intended to provide illumination, process electronic signals transmitted from a video endoscope and enable image recording.
- This product can be used in combination with compatible medical endoscope, a monitor, a recorder and various peripherals.
- It supplies air through the endoscope, for obtaining clear visualization and is used for endoscopic observation, diagnosis and treatment.
- BLI (Blue Light Imaging), LCI (Linked Color Imaging), ACI (Amber-red Color Imaging) and FICE (Flexible spectral-Imaging Color Enhancement) are adjunctive tools for gastrointestinal endoscopic examinations which can be used to supplement Fujifilm white light endoscopy.
BLI, LCI, ACI and FICE are not intended to replace histopathological sampling as a means of diagnosis.
- BLI, LCI, ACI and FICE are not intended for bronchoscopic examination.
FUJIFILM CORPORATION
EP-8000
In Commercial Distribution
- 04547410513790 ()
- Endoscopic video image processing/light source system
A dressing tissue forcep is a medical instrument typically used in surgical procedures. It is a handheld tool with two blades that are connected by a hinge, allowing the user to grasp and manipulate tissues or dressings with precision and control.
The blades of a dressing tissue forcep are usually long and slender, with a pointed tip at the end of each blade for grasping tissue. The jaws of the forcep may be serrated or smooth, depending on the intended use.
Dressing tissue forceps may be made of stainless steel or other materials that are easy to clean and sterilize. Some models may have a locking mechanism to hold tissues or dressings in place during procedures.
Overall, dressing tissue forceps are versatile and essential tools for many surgical procedures, allowing medical professionals to perform delicate and precise maneuvers with ease.
CONCISE ENTERPRISES
150295214
In Commercial Distribution
- G20215039521415 ()
15-02952-14
- Dressing/utility forceps, tweezers-like, reusable
The Dental Low-speed Handpiece is the dental clinic, hospital treatment for patients with tooth disease tools, which is an effective instrument for drilling, grinding, repairing. It composed of handpiece and a connector, including low speed air motor, straight handpiece and geared angle handpiece, for the model LN and L. The device description of the Dental Low-speed Handpiece is as following:
The gear ratios of handpieces have various gear ratios (for different geared angle handpiece) (1:1 (constant), 20:1 (speed reduction) and 1:5 (speed increase));
The handpieces have maximum Forward rotation speed 19000 rpm and maximum Reverse rotation speed of 18000 rpm.
The air motors are capable of running up to a speed of 22000 rpm, but different at different pressure of air supply; refer to section 2.3 for details.
The handle is slide-proof, comfortable and easy to clean. Handpiece and adaptors can bear steam disinfection at 135°C. The head angle can provide better operational vision and angle so that work efficiency can be improved. Cartridges have high precision when rotating; cartridges have low noise and high efficiency. The scope of application: for dental professional use only.
Lubricant should be used during routine maintenance (e.g. after each patient use and prior to sterilization).
Guangdong JINME Medical Technology Co., Ltd.
LN, L
In Commercial Distribution
- 06971119540029 ()
- Dental power tool system handpiece, pneumatic
The SACRONAIL system provides a sustained, stable restoration of dorsal pelvic fractures and sacral fractures through its intraosseous location and its direct, bi-iliac symmetric anchorage. The implant consists of a nail of various lengths from135mm to 194mm with a constant diameter of 8mm and 2 locking screws in different lengths. This variation ensures adaptation to the respective anatomy of the patient. The intersections of the screw axes to the implant axis have a distance of 15mm to the respective end face of the nail. This ensures a solid support on the lateral cortex of the Ilia. The angle of the screw axes to the implant axis corresponds to the anatomical conditions and is 70°. The locking screw ensures a stable connection of the components. The tips of the locking screws are rounded to facilitate insertion into the nail while the dorsal ends of locking screws are a hexagon. The caps serve to close the instrument connection of the nail. The implants are made from the Titanium alloy (Ti6Al4V) according to ASTM F 136 / ISO 5832-3, with a Type II anodization according to AMS 2488. There are Instruments which are specific to the implantation of the SACRONAIL device. These include, but are not limited to, the Guide Frame, the Guide Bracket, the Fixation Bracket, various Instrument Guides, various dilators and drills, screwdrivers as well as the specific tools for revision of the device.
SIGNUS Medizintechnik GmbH
Clamping screw
In Commercial Distribution
- 04047844057704 ()
PBZ0001-9
- Orthopaedic surgical procedure kit, non-medicated, reusable
The SACRONAIL system provides a sustained, stable restoration of dorsal pelvic fractures and sacral fractures through its intraosseous location and its direct, bi-iliac symmetric anchorage. The implant consists of a nail of various lengths from135mm to 194mm with a constant diameter of 8mm and 2 locking screws in different lengths. This variation ensures adaptation to the respective anatomy of the patient. The intersections of the screw axes to the implant axis have a distance of 15mm to the respective end face of the nail. This ensures a solid support on the lateral cortex of the Ilia. The angle of the screw axes to the implant axis corresponds to the anatomical conditions and is 70°. The locking screw ensures a stable connection of the components. The tips of the locking screws are rounded to facilitate insertion into the nail while the dorsal ends of locking screws are a hexagon. The caps serve to close the instrument connection of the nail. The implants are made from the Titanium alloy (Ti6Al4V) according to ASTM F 136 / ISO 5832-3, with a Type II anodization according to AMS 2488. There are Instruments which are specific to the implantation of the SACRONAIL device. These include, but are not limited to, the Guide Frame, the Guide Bracket, the Fixation Bracket, various Instrument Guides, various dilators and drills, screwdrivers as well as the specific tools for revision of the device.
SIGNUS Medizintechnik GmbH
Fixation screw
In Commercial Distribution
- 04047844057681 ()
PBZ0001-7
- Orthopaedic surgical procedure kit, non-medicated, reusable
The SACRONAIL system provides a sustained, stable restoration of dorsal pelvic fractures and sacral fractures through its intraosseous location and its direct, bi-iliac symmetric anchorage. The implant consists of a nail of various lengths from135mm to 194mm with a constant diameter of 8mm and 2 locking screws in different lengths. This variation ensures adaptation to the respective anatomy of the patient. The intersections of the screw axes to the implant axis have a distance of 15mm to the respective end face of the nail. This ensures a solid support on the lateral cortex of the Ilia. The angle of the screw axes to the implant axis corresponds to the anatomical conditions and is 70°. The locking screw ensures a stable connection of the components. The tips of the locking screws are rounded to facilitate insertion into the nail while the dorsal ends of locking screws are a hexagon. The caps serve to close the instrument connection of the nail. The implants are made from the Titanium alloy (Ti6Al4V) according to ASTM F 136 / ISO 5832-3, with a Type II anodization according to AMS 2488. There are Instruments which are specific to the implantation of the SACRONAIL device. These include, but are not limited to, the Guide Frame, the Guide Bracket, the Fixation Bracket, various Instrument Guides, various dilators and drills, screwdrivers as well as the specific tools for revision of the device.
SIGNUS Medizintechnik GmbH
Fixation arm
In Commercial Distribution
- 04047844057674 ()
PBZ0001-6
- Orthopaedic surgical procedure kit, non-medicated, reusable
The SACRONAIL system provides a sustained, stable restoration of dorsal pelvic fractures and sacral fractures through its intraosseous location and its direct, bi-iliac symmetric anchorage. The implant consists of a nail of various lengths from135mm to 194mm with a constant diameter of 8mm and 2 locking screws in different lengths. This variation ensures adaptation to the respective anatomy of the patient. The intersections of the screw axes to the implant axis have a distance of 15mm to the respective end face of the nail. This ensures a solid support on the lateral cortex of the Ilia. The angle of the screw axes to the implant axis corresponds to the anatomical conditions and is 70°. The locking screw ensures a stable connection of the components. The tips of the locking screws are rounded to facilitate insertion into the nail while the dorsal ends of locking screws are a hexagon. The caps serve to close the instrument connection of the nail. The implants are made from the Titanium alloy (Ti6Al4V) according to ASTM F 136 / ISO 5832-3, with a Type II anodization according to AMS 2488. There are Instruments which are specific to the implantation of the SACRONAIL device. These include, but are not limited to, the Guide Frame, the Guide Bracket, the Fixation Bracket, various Instrument Guides, various dilators and drills, screwdrivers as well as the specific tools for revision of the device.
SIGNUS Medizintechnik GmbH
Instrument guide
In Commercial Distribution
- 04047844057650 ()
- 145/160/174/190mm
PBZ0001-4
- Orthopaedic surgical procedure kit, non-medicated, reusable
The SACRONAIL system provides a sustained, stable restoration of dorsal pelvic fractures and sacral fractures through its intraosseous location and its direct, bi-iliac symmetric anchorage. The implant consists of a nail of various lengths from135mm to 194mm with a constant diameter of 8mm and 2 locking screws in different lengths. This variation ensures adaptation to the respective anatomy of the patient. The intersections of the screw axes to the implant axis have a distance of 15mm to the respective end face of the nail. This ensures a solid support on the lateral cortex of the Ilia. The angle of the screw axes to the implant axis corresponds to the anatomical conditions and is 70°. The locking screw ensures a stable connection of the components. The tips of the locking screws are rounded to facilitate insertion into the nail while the dorsal ends of locking screws are a hexagon. The caps serve to close the instrument connection of the nail. The implants are made from the Titanium alloy (Ti6Al4V) according to ASTM F 136 / ISO 5832-3, with a Type II anodization according to AMS 2488. There are Instruments which are specific to the implantation of the SACRONAIL device. These include, but are not limited to, the Guide Frame, the Guide Bracket, the Fixation Bracket, various Instrument Guides, various dilators and drills, screwdrivers as well as the specific tools for revision of the device.
SIGNUS Medizintechnik GmbH
Instrument guide
In Commercial Distribution
- 04047844057643 ()
- 140/154/170/186mm
PBZ0001-3
- Orthopaedic surgical procedure kit, non-medicated, reusable