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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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IPP-ON® - 10381780045038

The proximal PIP Fusion hand drill is used to prepare the proximal phalanx and to define the size of the implant. This model is size 2.
NEWDEAL
239022ND
In Commercial Distribution

  • M248239022ND1 ()
  • 10381780045038 ()

  • 2.8mm tip diam.; 14.50mm drill length; 60° tip angle


  • Manual surgical rotary handpiece, reusable

IPP-ON® - 10381780045021

The distal PIP Fusion hand drill is used to prepare the distal phalanx and to define the size of the implant. This model is size 2.
NEWDEAL
239021ND
In Commercial Distribution

  • M248239021ND1 ()
  • 10381780045021 ()

  • 3.8mm tip diam.; 6.50mm drill length; 90° tip angle


  • Manual surgical rotary handpiece, reusable

IPP-ON® - 10381780045014

The proximal PIP Fusion hand drill is used to prepare the proximal phalanx and to define the size of the implant. This model is size 1.
NEWDEAL
239012ND
In Commercial Distribution

  • M248239012ND1 ()
  • 10381780045014 ()

  • 2.4mm tip diam.; 14.50mm drill length; 60° tip angle


  • Manual surgical rotary handpiece, reusable

IPP-ON® - 10381780045007

The distal PIP Fusion hand drill is used to prepare the distal phalanx and to define the size of the implant. This model is size 1.
NEWDEAL
239011ND
In Commercial Distribution

  • M248239011ND1 ()
  • 10381780045007 ()

  • 3.0mm tip diam.; 6.50mm drill length; 90° tip angle


  • Manual surgical rotary handpiece, reusable

SONICflex 2008 L - EKAV100593100

This is a medical device.The dental treatment unit running as a desktop unit is intended for use in the field of dentistry. It is designed for the operation of an electrically operated small voltage motor. Area of application is in the field of endodontics and tooth preparation. The ELECTROmatic is intended to convert pneumatic output from a dental treatment center to electrical energy for operation of electrically-driven dental handpieces. This device is designed for use by a trained professional in the field of general dentistry.
KaVo Dental GmbH
1.005.9310
In Commercial Distribution

  • EKAV100593100 ()
2008 L

  • Ultrasonic dental scaling/debridement system

SONICflex scaler Tip No. 7 (A) - EKAV100589510

This is a medical device.The dental treatment unit running as a desktop unit is intended for use in the field of dentistry. It is designed for the operation of an electrically operated small voltage motor. Area of application is in the field of endodontics and tooth preparation. The ELECTROmatic is intended to convert pneumatic output from a dental treatment center to electrical energy for operation of electrically-driven dental handpieces. This device is designed for use by a trained professional in the field of general dentistry.
KaVo Dental GmbH
1.005.8951
In Commercial Distribution

  • EKAV100589510 ()
scaler Tip No 7 A

  • Ultrasonic dental scaling/debridement system

INTRAmatic 31 ES - EKAV100311090

This is a medical device.The dental treatment unit running as a desktop unit is intended for use in the field of dentistry. It is designed for the operation of an electrically operated small voltage motor. Area of application is in the field of endodontics and tooth preparation. The ELECTROmatic is intended to convert pneumatic output from a dental treatment center to electrical energy for operation of electrically-driven dental handpieces. This device is designed for use by a trained professional in the field of general dentistry.
KaVo Dental GmbH
1.003.1109
In Commercial Distribution

  • EKAV100311090 ()
31 ES

  • Dental power tool system handpiece, line-powered

Calibration body EM - B057U1038020

The Calibration body EM is used to calibrate a surgical endoscope which is tracked with Endoscope tracker EM. The location of the Calibration Body EM is referenced relative to the Endoscope tracker EM and allows Navigation Software NOVA AR to compute the optical parameters of the attached surgical endoscope. The Calibration body EM connects to the Hybrid Navigation Unit EM via an integrated cable. The Calibration body EM is provided non-sterile and is intended to be sterilized by the user. The Calibration body EM is reusable.
Scopis GmbH
1.0
In Commercial Distribution

  • B057U1038020 ()
U1 038 02

  • Electromagnetic surgical navigation device tracking system

Instrument port - B057U1049010

The Instrument port is a sterile handling port for the other EM navigated instruments. The Instrument port connects to the Hybrid Navigation Unit EM on one side and to an EM navigated instrument on the other. The Instrument port is provided non-sterile and is intended to be sterilized by the user. The Instrument port is reusable.
Scopis GmbH
1.0
In Commercial Distribution

  • B057U1049010 ()
U1 049 01

  • Electromagnetic surgical navigation device tracking system

SmartBone - 00811813020235

The SmartBone is a 3D-printed, patient-specific device that is used to set the Glenoid Intelligent Reusable Instrument (IRI) at the time of surgery. This bone model is a 1-to-1 representation of a specific patient's bony anatomy. The SmartBone is indicated for use as part of the Arthrex Glenoid Intelligent Reusable Instrument System (IRIS) for Total Shoulder Arthroplasty (TSA).
CUSTOM ORTHOPAEDIC SOLUTIONS, INC.
A
Not in Commercial Distribution

  • 00811813020235 ()

  • Patient-specific
0006-0007-UPI

  • Orthopaedic prosthesis implantation positioning instrument, single-use
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