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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 SABE/MSIL ACCUQ
Bernafon AG
182136
In Commercial Distribution

  • 05711584079720 ()


  • Air-conduction hearing aid, receiver-in-the-ear
The Compact is intended for breaking apart urinary tract stones, e.g., renal calyceal, renal pelvic, and ureteral stones. The purpose of the Shock Wave Generator is to convert the electric energy stored in a capacitor into mechanical energy. By generating high-energy sparks under water, shock waves are produced. The reflectors then focus these waves to converge at the common therapeutic focal point (F2).
DIREX SYSTEMS CORP.
COMPACT
In Commercial Distribution

  • 00863499000346 ()


  • Spark-gap lithotripsy system
AQ CO9 MNR, 2.4G NFM PB SABE/MAC ACCUQ
Bernafon AG
181961
In Commercial Distribution

  • 05711584079256 ()


  • Air-conduction hearing aid, receiver-in-the-ear
3Dscope is intended for acquisition, processing and display of fluoroscopy images. It can be also used together with an extra-corporeal shockwave lithotripsy. 3Dscope enables: • Visualization of various objects on fluoroscopy images (for example, kidney stones). • Generation and storage of patient records. • Comparing images obtained at different times. • Generation and management of patient data files and fluoroscopy images. The device is composed of the following units: • Workstation Console, which contains the application software for the system indicators and image display of the following:  System status  Fluoroscopy images • Gantry unit, which contains he HF X-Ray generator, image intensifier and digital camera. It performs the following:  Generator control  Image initial processing  Data transfer to the Workstation console.
DIREX SYSTEMS CORP.
3DSCOPE
In Commercial Distribution

  • 00863499000322 ()


  • Fluoroscopic x-ray system video image recording unit
AQ CO9 MNR, 2.4G NFM PB COBR ACCUQ
Bernafon AG
181959
In Commercial Distribution

  • 05711584079232 ()


  • Air-conduction hearing aid, receiver-in-the-ear
AQ CO9 MNR, 2.4G NFM PB JEBL ACCUQ
Bernafon AG
181958
In Commercial Distribution

  • 05711584079225 ()


  • Air-conduction hearing aid, receiver-in-the-ear
AQ CO9 MNR, 2.4G NFM PB MAC ACCUQ
Bernafon AG
181957
In Commercial Distribution

  • 05711584079218 ()


  • Air-conduction hearing aid, receiver-in-the-ear
AQ CO9 MNR, 2.4G NFM PB MSIL/MAC ACCUQ
Bernafon AG
181954
In Commercial Distribution

  • 05711584079188 ()


  • Air-conduction hearing aid, receiver-in-the-ear
AQ CO9 MNR, 2.4G NFM PB SABE/MSIL ACCUQ
Bernafon AG
181953
In Commercial Distribution

  • 05711584079171 ()


  • Air-conduction hearing aid, receiver-in-the-ear
AQ CO9 MNR T, 2.4G NFM DPB ANBR ACCUQ
Bernafon AG
182145
In Commercial Distribution

  • 05711584078716 ()


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