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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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roclub TeleOperationPlatform (rTOP) is a medical device (including hardware and software) for geographically distant technologist or radiologists to remotely assist with operating imaging equipment and radiotherapeutic devices. rTOP provides a private, secure communication platform for real-time image visualization and cross-organizational collaboration between healthcare professionals across multiple sites. rTOP enables remote access to modality consoles and enhances communication capabilities between healthcare professionals across different locations. It is vendor-neutral and applicable to existing multimodalities in a healthcare network, a solution that allows healthcare professionals to share expertise and increase productivity, even when they are not physically present in the same location. rTOP is based on a client server architecture, with a cloud infrastructure as the backbone and 2 different variants of client, based on the user roles, local operator and remote operator. The remote operator app is a web client which runs in a web browser. The local operator establishes remote connection to the remote operator through the roclub connector (rC) including a video splitter and emulation of mouse and keyboard. The remote operator can establish connections to more than one rC. Additional remote operators can connect for assistance or training purposes. The connection is possible in full control or read-only mode. The access to the system must be granted by the local user using the system. The access to the system can be revoked at any time by the local user, thus allowing the local user full control of the session at all times. The full-control accessibility to higher risk modalities with physical switches (CT scanners) is limited to the software associated with the modality workplace and is not applicable to the physical switches controlling the equipment operation.
roclub GmbH
1
Not in Commercial Distribution

  • 09120138870014 ()
-

  • Radiology DICOM image processing application software
rebless™ (Model: RHBD) has been designed to provide a safe and efficient solution for individuals recovering after joint surgeries, injuries, neurological movement disorders improving range of motion, muscle strength, and enhancing overall physical performance. This device incorporates robotic and isokinetic technology, making it a versatile and essential tool for physical therapy clinics, sports medicine facilities, and home use. rebless™ (Model: RHBD) is a robotic, exercise therapy device for both upper and lower limbs, providing motion to the elbow, wrist, ankle, and knee joints. With multiple operating modes, rebless™ allows for passive and active-assisted range of motion and resisted exercise, so therapy can be customized based on each individual patient’s condition and progress. rebless™ is controlled through an app downloaded onto the patient’s smartphone or mobile device. rebless™ provides therapeutic treatment at home or in clinics for patients suffering from neurological or musculoskeletal conditions. Key features: 1) Isokinetic: The standout feature of rebless™ (Model: RHBD) device is its isokinetic functionality. Isokinetic exercise ensures that resistance remains constant throughout a range of motion, adapting to the user's force output. This capability is particularly valuable in rehab settings, allowing patients to exercise at a pace that suits their recovery and minimizing the risk of further injury. 2) Adjustable resistance: The device provides a wide range of adjustable resistance settings, accommodating to apply resistance level based on their abilities. This adaptability is crucial for progression in rehabilitation and training programs. 3) Adjustable assistance: The device provides a wide range of adjustable assistance settings, to apply assistance level based on their abilities. This adaptability is crucial for progression in rehabilitation and training programs.
H ROBOTICS INC.
RHDB
In Commercial Distribution

  • 08800101600183 ()
1

  • Continuous passive motion joint exerciser
The MOR is a self-tapping, small diameter, screw implant, manufactured from titanium alloy (6% Al, 4% V – ASTM F136). The portion of the implant that is submerged in the bone is grit blasted and acid etched. The implants are manufactured with two body diameters, 2.1 mm and 2.4 mm. They are packaged sterile in a double blister, which contains: the implant in a titanium tube. The MOR implant body is designed with an O-ball denture connection and a separate straight titanium alloy (6% AI, 4% V – ASTM F136) abutment which may be cemented over the O-ball for crown or bridge fixation. The MOR Implant System is not intended for correction of implants placed at an angle. It is only intended for use with straight abutments. The MOR implant body is intended to be placed such that no angle correction is necessary. It is intended for long-term applications in the bone of the patient’s upper or lower arch. The MOR implants may also be used for inter-radicular transitional applications. These devices will permit immediate splinting stability and long-term fixation of new or existing crown and bridge installations, for full or partial edentulous cases, and employing minimally invasive surgical intervention.
STERNGOLD DENTAL LLC
901493
In Commercial Distribution

  • 00841549108273 ()


  • Screw endosteal dental implant, one-piece
The MOR is a self-tapping, small diameter, screw implant, manufactured from titanium alloy (6% Al, 4% V – ASTM F136). The portion of the implant that is submerged in the bone is grit blasted and acid etched. The implants are manufactured with two body diameters, 2.1 mm and 2.4 mm. They are packaged sterile in a double blister, which contains: the implant in a titanium tube. The MOR implant body is designed with an O-ball denture connection and a separate straight titanium alloy (6% AI, 4% V – ASTM F136) abutment which may be cemented over the O-ball for crown or bridge fixation. The MOR Implant System is not intended for correction of implants placed at an angle. It is only intended for use with straight abutments. The MOR implant body is intended to be placed such that no angle correction is necessary. It is intended for long-term applications in the bone of the patient’s upper or lower arch. The MOR implants may also be used for inter-radicular transitional applications. These devices will permit immediate splinting stability and long-term fixation of new or existing crown and bridge installations, for full or partial edentulous cases, and employing minimally invasive surgical intervention.
STERNGOLD DENTAL LLC
901492
In Commercial Distribution

  • 00841549108266 ()


  • Screw endosteal dental implant, one-piece
The MOR is a self-tapping, small diameter, screw implant, manufactured from titanium alloy (6% Al, 4% V – ASTM F136). The portion of the implant that is submerged in the bone is grit blasted and acid etched. The implants are manufactured with two body diameters, 2.1 mm and 2.4 mm. They are packaged sterile in a double blister, which contains: the implant in a titanium tube. The MOR implant body is designed with an O-ball denture connection and a separate straight titanium alloy (6% AI, 4% V – ASTM F136) abutment which may be cemented over the O-ball for crown or bridge fixation. The MOR Implant System is not intended for correction of implants placed at an angle. It is only intended for use with straight abutments. The MOR implant body is intended to be placed such that no angle correction is necessary. It is intended for long-term applications in the bone of the patient’s upper or lower arch. The MOR implants may also be used for inter-radicular transitional applications. These devices will permit immediate splinting stability and long-term fixation of new or existing crown and bridge installations, for full or partial edentulous cases, and employing minimally invasive surgical intervention.
STERNGOLD DENTAL LLC
901491
In Commercial Distribution

  • 00841549108259 ()


  • Screw endosteal dental implant, one-piece
The MOR is a self-tapping, small diameter, screw implant, manufactured from titanium alloy (6% Al, 4% V – ASTM F136). The portion of the implant that is submerged in the bone is grit blasted and acid etched. The implants are manufactured with two body diameters, 2.1 mm and 2.4 mm. They are packaged sterile in a double blister, which contains: the implant in a titanium tube. The MOR implant body is designed with an O-ball denture connection and a separate straight titanium alloy (6% AI, 4% V – ASTM F136) abutment which may be cemented over the O-ball for crown or bridge fixation. The MOR Implant System is not intended for correction of implants placed at an angle. It is only intended for use with straight abutments. The MOR implant body is intended to be placed such that no angle correction is necessary. It is intended for long-term applications in the bone of the patient’s upper or lower arch. The MOR implants may also be used for inter-radicular transitional applications. These devices will permit immediate splinting stability and long-term fixation of new or existing crown and bridge installations, for full or partial edentulous cases, and employing minimally invasive surgical intervention.
STERNGOLD DENTAL LLC
901489
In Commercial Distribution

  • 00841549108235 ()


  • Screw endosteal dental implant, one-piece
The MOR is a self-tapping, small diameter, screw implant, manufactured from titanium alloy (6% Al, 4% V – ASTM F136). The portion of the implant that is submerged in the bone is grit blasted and acid etched. The implants are manufactured with two body diameters, 2.1 mm and 2.4 mm. They are packaged sterile in a double blister, which contains: the implant in a titanium tube. The MOR implant body is designed with an O-ball denture connection and a separate straight titanium alloy (6% AI, 4% V – ASTM F136) abutment which may be cemented over the O-ball for crown or bridge fixation. The MOR Implant System is not intended for correction of implants placed at an angle. It is only intended for use with straight abutments. The MOR implant body is intended to be placed such that no angle correction is necessary. It is intended for long-term applications in the bone of the patient’s upper or lower arch. The MOR implants may also be used for inter-radicular transitional applications. These devices will permit immediate splinting stability and long-term fixation of new or existing crown and bridge installations, for full or partial edentulous cases, and employing minimally invasive surgical intervention.
STERNGOLD DENTAL LLC
901488
In Commercial Distribution

  • 00841549108228 ()


  • Screw endosteal dental implant, one-piece
The MOR is a self-tapping, small diameter, screw implant, manufactured from titanium alloy (6% Al, 4% V – ASTM F136). The portion of the implant that is submerged in the bone is grit blasted and acid etched. The implants are manufactured with two body diameters, 2.1 mm and 2.4 mm. They are packaged sterile in a double blister, which contains: the implant in a titanium tube. The MOR implant body is designed with an O-ball denture connection and a separate straight titanium alloy (6% AI, 4% V – ASTM F136) abutment which may be cemented over the O-ball for crown or bridge fixation. The MOR Implant System is not intended for correction of implants placed at an angle. It is only intended for use with straight abutments. The MOR implant body is intended to be placed such that no angle correction is necessary. It is intended for long-term applications in the bone of the patient’s upper or lower arch. The MOR implants may also be used for inter-radicular transitional applications. These devices will permit immediate splinting stability and long-term fixation of new or existing crown and bridge installations, for full or partial edentulous cases, and employing minimally invasive surgical intervention.
STERNGOLD DENTAL LLC
901485
In Commercial Distribution

  • 00841549108211 ()


  • Screw endosteal dental implant, one-piece
The MOR is a self-tapping, small diameter, screw implant, manufactured from titanium alloy (6% Al, 4% V – ASTM F136). The portion of the implant that is submerged in the bone is grit blasted and acid etched. The implants are manufactured with two body diameters, 2.1 mm and 2.4 mm. They are packaged sterile in a double blister, which contains: the implant in a titanium tube. The MOR implant body is designed with an O-ball denture connection and a separate straight titanium alloy (6% AI, 4% V – ASTM F136) abutment which may be cemented over the O-ball for crown or bridge fixation. The MOR Implant System is not intended for correction of implants placed at an angle. It is only intended for use with straight abutments. The MOR implant body is intended to be placed such that no angle correction is necessary. It is intended for long-term applications in the bone of the patient’s upper or lower arch. The MOR implants may also be used for inter-radicular transitional applications. These devices will permit immediate splinting stability and long-term fixation of new or existing crown and bridge installations, for full or partial edentulous cases, and employing minimally invasive surgical intervention.
STERNGOLD DENTAL LLC
901484
In Commercial Distribution

  • 00841549108204 ()


  • Screw endosteal dental implant, one-piece
The MOR is a self-tapping, small diameter, screw implant, manufactured from titanium alloy (6% Al, 4% V – ASTM F136). The portion of the implant that is submerged in the bone is grit blasted and acid etched. The implants are manufactured with two body diameters, 2.1 mm and 2.4 mm. They are packaged sterile in a double blister, which contains: the implant in a titanium tube. The MOR implant body is designed with an O-ball denture connection and a separate straight titanium alloy (6% AI, 4% V – ASTM F136) abutment which may be cemented over the O-ball for crown or bridge fixation. The MOR Implant System is not intended for correction of implants placed at an angle. It is only intended for use with straight abutments. The MOR implant body is intended to be placed such that no angle correction is necessary. It is intended for long-term applications in the bone of the patient’s upper or lower arch. The MOR implants may also be used for inter-radicular transitional applications. These devices will permit immediate splinting stability and long-term fixation of new or existing crown and bridge installations, for full or partial edentulous cases, and employing minimally invasive surgical intervention.
STERNGOLD DENTAL LLC
901483
In Commercial Distribution

  • 00841549108198 ()


  • Screw endosteal dental implant, one-piece
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