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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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AQ CO7 MNR T, 2.4G NFM DPB MAC ACCUQ
Bernafon AG
182150
In Commercial Distribution

  • 05711584079775 ()


  • Air-conduction hearing aid, receiver-in-the-ear
AQ CO7 MNR T, 2.4G NFM DPB MSIL/MAC ACCUQ
Bernafon AG
182148
In Commercial Distribution

  • 05711584079751 ()


  • Air-conduction hearing aid, receiver-in-the-ear
No Description
Giles Scientific, Inc.
V3
In Commercial Distribution

  • 00863504000217 ()
BV3

  • Antimicrobial susceptibility/resistance testing interpretive software IVD
  • Colony counter IVD, automated/semi-automated
AQ CO7 MNR T, 2.4G NFM DPB SABE/MAC ACCUQ
Bernafon AG
182135
In Commercial Distribution

  • 05711584079713 ()


  • Air-conduction hearing aid, receiver-in-the-ear
The Duet is indicated for use in the fragmentation of urinary tract stones (i.e. renal calyceal, renal pelvic, and upper ureteral stones). The Duet is a transportable Extracorporeal Shock Wave Lithotripsy device, which consists of Shock Wave Generator (SWAG), a Motorized Floating Treatment Table (MFT), and Computer Console. The Duet does not provide imaging or monitoring functions, but contain the necessary interfaces for fluoroscopy and ECG R Wave Synchronization. The Duet is small and Transportable and can be used in any room equipped with the proper anesthesia devices. Special electrodes placed within two reflectors generate high-energy sparks, which can be controlled within defined limits. The shock waves generated by the sparks are focused through water and through the body to converge on the calculus. The shock waves must be generated and transmitted through liquid to assure that sufficient energy is delivered to the stone. A series of the focused shock waves is used for the stone disintegration.
DIREX SYSTEMS CORP.
COMPACT DUET
In Commercial Distribution

  • 00863499000339 ()


  • Spark-gap lithotripsy system
AQ CO9 MNR, 2.4G NFM PB ANBR ACCUQ
Bernafon AG
181960
In Commercial Distribution

  • 05711584079249 ()


  • Air-conduction hearing aid, receiver-in-the-ear
INTEGRA is a transportable Electromagnetic (EM) Extracorporeal Shock Wave Lithotripter (ESWL) used for urinary stones treatment. The device consists of the following: • UCON • Integrated unit, includes the following:  Shock Wave Generator (SWAG)  Fluoroscopy device (X-Ray Module)  Patient Table The SWAG includes a high voltage generator module, a Reflector module, and a water module, and is located under the patient table. The Reflector is mechanically coupled to an X-Ray Tube Monoblock. The Reflector/ Monoblock assembly is attached via a U-arm to an Image Intensifier and a digital camera Module, for real time stone imaging. The U-Arm assembly is motorized, such that all three modules (Reflector, Monoblock, and Image Intensifier) move simultaneously as one piece and can be displaced electrically in all three axes, thus enabling the stone to be lined up in the therapeutic focal point. The patient and table do not move. The patient lies still on the table and only the U-Arm Assembly moves until the stone is localized. The UCON enables control over all operational aspects of the integrated unit via a software application. The operator chooses the various parameters to control the treatment including the number of shocks, intensity, frequency, etc. INTEGRA contains the necessary interfaces for ECG synchronization and ultrasonic imaging devices. INTEGRA can be used in any room equipped with the proper anesthesia equipment.
DIREX SYSTEMS CORP.
INTEGRA
In Commercial Distribution

  • 00863499000315 ()


  • Electromechanical lithotripsy system, extracorporeal
Duet Magna is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and the upper ureter. The device incorporates two electromagnetic shockwaves transducers at complementary angles to the horizon. The transducers can be operated separately (Top/Bottom) or alternate. A series of focused shockwaves produced by electromagnetic transducers are coupled to a patient flank and are made to converge on urinary stones and disintegrate them. The patient is placed on a treatment table and x-ray and/or ultrasonic imaging device to localize the stone. The operator controls treatment parameters including shockwave intensity, pulse rate, the number of shocks and ECG Synchronization.
DIREX SYSTEMS CORP.
MAGNA
In Commercial Distribution

  • 00863499000308 ()
10-MGNA-000

  • Electromechanical lithotripsy system, extracorporeal
AQ CO9 MNR, 2.4G NFM PB MAC/MSIL ACCUQ
Bernafon AG
181956
In Commercial Distribution

  • 05711584079201 ()


  • Air-conduction hearing aid, receiver-in-the-ear
AQ CO9 MNR, 2.4G NFM PB MSIL ACCUQ
Bernafon AG
181955
In Commercial Distribution

  • 05711584079195 ()


  • Air-conduction hearing aid, receiver-in-the-ear
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