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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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This is a plastic box outside a drug bag less than or equal to 100ml.
INFUTRONIX LLC
Nimbus Hard Shell 100ml
In Commercial Distribution

  • 00817170020154 ()
  • 20817170020158 ()
  • 10817170020151 ()


  • Patient-controlled analgesia infusion pump
  • Ambulatory non-insulin infusion pump, electronic
The PhotonGuide is intended to provide surgical site illumination from a high intensity light source.
INVUITY, INC.
Wide / Angled
In Commercial Distribution


  • Width: Wide
  • Angle: Angled
102521

  • Surgical instrument fibreoptic light
The PhotonGuide is intended to provide surgical site illumination from a high intensity light source.
INVUITY, INC.
Narrow / Angled
In Commercial Distribution

  • 00816728020097 ()

  • Angle: Angled
  • Width: Narrow
104001

  • Surgical instrument fibreoptic light
The PhotonGuide is intended to provide surgical site illumination from a high intensity light source.
INVUITY, INC.
Wide / Angled
In Commercial Distribution

  • 00816728020066 ()

  • Angle: Angled
  • Width: Wide
102521

  • Surgical instrument fibreoptic light
One hand and wrist support. Made of cloth, the device is worn on the body
Guangzhou Xinbo Electronic Co., Ltd.
NN-WR-Blue
In Commercial Distribution

  • 06970742221718 ()


  • Elbow/wrist/hand orthosis
A fluorometer for clinical use is a device intended to measure by fluorescence certain analytes
Guangzhou Labsim Biotech Co., Ltd
AFS-1000
In Commercial Distribution

  • 06970136030216 ()


  • Fluorescent immunoassay analyser IVD, laboratory, semi-automated
A fluorometer for clinical use is a device intended to measure by fluorescence certain analytes
Guangzhou Labsim Biotech Co., Ltd
AFS2000A
In Commercial Distribution

  • 06970136030100 ()


  • Fluorescent immunoassay analyser IVD, laboratory, semi-automated
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.The ELECTROmatic dental control unit is a stand-alone system for operating electrically-driven KaVo handpieces. External power supply provides electric power to the unit. The 4-hole tubing connected to the unit supplies chip /cooling air, water and pressure signal. The speed of the electric handpiece is controlled by air pressure. The control unit is positioned close to a treatment unit at thelocation preferred by the dentist. The ELECTROmatic system consists of a base unit with a motor hose, an electrical motor, a transformer, and a power cord. 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
1.003.1107
In Commercial Distribution

  • EKAV100311070 ()
20 E

  • Dental power tool system handpiece, line-powered
The battery charger type PECGC-III is an accessory to the PocketECG III - Medicalgorithmics Unified Arrhythmia Diagnostic System. The charger is intended to be used for charging the PECGB-III batteries used with PocketECG transmitter.
MEDICALGORITHMICS S A
Type: PECGC-III
In Commercial Distribution

  • 05903021560049 ()


  • Electrocardiography telemetric monitoring system
The RANDOX evidence® system is a fully automated, continuous access immunoanalyser using protein biochip array technology. It is intended for the in-vitro qualitative, semi-quantitative or fully quantitative determination of various diagnostic markers.
RANDOX LABORATORIES LIMITED
EV3600
In Commercial Distribution

  • 05055273214024 ()
EV3600

  • Multiplex analyser IVD, laboratory, automated
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