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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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Is a foot bed wearable device that affords the patient the ability to perform exercises both at home and in clinic settings that also allows the provider the ability to make clinical judgments pursuant data collected from the patient via customizable rehabilitative protocols set, and amended, by the provider.
MEDHAB, LLC
7 Size (00)
In Commercial Distribution

  • 00850023296030 ()
Shoe insole size 00 (women 3.0 to 6.5)

  • Pressure monitoring insole
No Description
Ray Co., Ltd
3.1.0.0
In Commercial Distribution

  • 08800003005017 ()


  • Dental treatment application software
The intraoral camera with a B applied Part is intended to provide a dentist with the ability to view the oral cavity prior to and subsequent to dental procedures. It can be connected to a USB hub that is connected to be directly connected to a Laptop or Desktop computer USB ports.
Osstem Implant Co.,Ltd.
SNAP Wired
In Commercial Distribution

  • 08800000995656 ()


  • Intraoral camera
This device is an oral camera device that can be magnified in the light of the inside of the mouth, and is used by dentists to photograph the inside of the mouth during oral examination. It consists of a camera head, a battery, a charging cradle, and a receiver module. Investigate the light from the mouth LED to capture the image from the camera module and wirelessly transmit the data via UWB. Additionally, the transmitted image can be viewed using a separate viewer program on the PC ti which the receiver module is connected.
Osstem Implant Co.,Ltd.
SNAP Wireless
In Commercial Distribution

  • 08800000995649 ()


  • Intraoral camera
VARO Plan Software is a stand-alone Windows-based software application to support the treatment planning for dental implantation. It is designed for qualified dental practitioners, including dentists and lab technicians. The software imports the medical image dataset of the patient in DICOM format from medical CT or dental CBCT scanners for pre-operative planning and simulation of dental placement. It is intended for use as pre-operative planning software for the placement of dental implant(s) based on imported CT image data, optionally aligned to an optical 3D surface scan. Virtual Crowns can be used for optimized implant positioning under the prosthetic aspect. The digital three dimensional model of a surgical guide for a guided surgery can be designed based on the approved implant position. This 3D data can be exported to manufacture a separate physical product. Indications of the dental implants do not change with guided surgery compared to conventional surgery. Use of the software requires that the user has the necessary medical training in implantology and surgical dentistry.
3D Industrial Imaging Co.,Ltd
1.0
In Commercial Distribution

  • 08800022900089 ()
1.0

  • Dental treatment application software
Dentiq3D is a 3D visualization software for the analysis of various dental CT data. Dentiq3D provides intuitive and real-time 3D volume processing functions.
3D Industrial Imaging Co.,Ltd
1.0
In Commercial Distribution

  • 08800022900003 ()
1.0

  • Dental treatment application software
No Description
DÜRR DENTAL SE
J2713
In Commercial Distribution

  • E247J27131 ()


  • Intraoral camera
No Description
DÜRR DENTAL SE
J2712
In Commercial Distribution

  • E247J27121 ()


  • Intraoral camera
Mammotome Revolve Control Module- Python
DEVICOR MEDICAL PRODUCTS, INC.
MSCM1
In Commercial Distribution

  • 00841911103165 ()
CA00006003

  • Mammographic stereotactic biopsy system
Control Module Revolve EX - ROW
DEVICOR MEDICAL PRODUCTS, INC.
MSCM1
In Commercial Distribution

  • 00841911102830 ()
CA000606001

  • Mammographic stereotactic biopsy system
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