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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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IDENTIFY - EHUQHQ0100707

The intended use of the device is to identify the patient and patient specific accessories and to guide the positioning of patients and accessories for radiosurgery or radiotherapy prodedures. The only location where the device is used is the radiologic diagnostic and radiation therapy department.
humediQ global GmbH
1.7
In Commercial Distribution

  • EHUQHQ0100707 ()
HQ01007

  • Radio-frequency identification patient positioning/tracking system application software

Cochlear™ Objective Measures - 09321502070416

Hearing implant software
COCHLEAR LIMITED
v 2.0
In Commercial Distribution

  • 09321502070416 ()
P1986795

  • Cochlear implant intraoperative electrophysiological analysis software

Nucleus® SmartNav - 09321502065917

Hearing implant software
COCHLEAR LIMITED
P1799437
In Commercial Distribution

  • 09321502065917 ()
P1799437

  • Cochlear implant intraoperative electrophysiological analysis software

Nucleus® - 09321502050708

Nucleus® SmartNav
COCHLEAR LIMITED
P1652770
In Commercial Distribution

  • 09321502050708 ()
P1652770

  • Cochlear implant intraoperative electrophysiological analysis software

Volpara Live - 09421904268340

No Description
VOLPARA HEALTH TECHNOLOGIES LIMITED
2.4
In Commercial Distribution

  • 09421904268340 ()


  • Radiological video camera patient positioning/tracking system software

Reference Plate Cover - 04953170077746

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-996
Not in Commercial Distribution

  • 04953170077746 ()


  • Sensor holder, reusable

RECEIVER DISH STAND SUPPLEMENTARY SET - 04953170305887

MAJ-1978 ScopeGuide RD Stand SET
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-1978
Not in Commercial Distribution

  • 04953170305887 ()


  • Sensor holder, reusable

RECEIVER DISH ARM - 04953170305856

MAJ-1962 MAJ-1692 ScopeGuide Receiver Di
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-1962
In Commercial Distribution

  • 04953170305856 ()


  • Sensor holder, reusable

HOLDER FOR HC-RP - 04953170305849

MAJ-1938 ScopeGuide Holder for HC-RC
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-1938
In Commercial Distribution

  • 04953170305849 ()
  • 84953170305845 ()
N3807700

  • Sensor holder, reusable

RECEIVER DISH STAND - 04953170305771

MAJ-1907 ScopeGuide Receiver Dish Stand
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-1907
In Commercial Distribution

  • 04953170305771 ()
N3807000

  • Sensor holder, reusable
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