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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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POLLOGEN LTD
STOP U MODEL UXV
In Commercial Distribution

  • 07290016586442 ()
34650000BP-US

  • Multi-modality skin/body contouring system
+ DAMON CLR SPK U/L 7-7 STD-TQ W. CLR U 5-5, L 3-3
ORMCO CORPORATION
740-1409
In Commercial Distribution

  • 00889989080506 ()

  • Slot size: .022"


  • Orthodontic bracket, ceramic
U/S PHAKO-HANDSTUECK HEXADISQ; U/S PHACO-HANDPIECE HEXADISQ; PIECE A MAIN PHACO HEXADISQ
Oertli-Instrumente AG
VG800011
In Commercial Distribution

  • 07630003902211 ()


  • Phacoemulsification system handpiece
ShangRing Male Circumcision Device Self-locking
Wuhu Snnda Medical Treatment Appliance Technology Co., Ltd.
U
In Commercial Distribution

  • 26939550822160 ()
  • 16939550822163 ()
  • 86939550822162 ()


  • Surgical penis clamp, single-use
The VuMAX HD Ophthalmic Ultrasound System is a non-invasive, active, bio-microscope (UBM) device for imaging ocular features for diagnostic purposes. It utilizes a 35 MHz and/or 50 MHz transducer with a sector scanning probe. B-scan settings include orbit, virtreous body, retina surface, and deep retina/choroid. UBM capabilities include sulcus-to-sulcus, angle detail, high resolution, and motion picture settings. The system includes the high frequency ultrasound system (UBM) including the base unit, 22" LCD, water-path probe, 35 MHz transducer, keyboard and mouse, USB foot switch, immersion cups and user manual.
SONOMED, INC.
VuMAX-HD UBM
In Commercial Distribution

  • 00896100002194 ()
U.575

  • Ophthalmic ultrasound imaging system
The VuPad Ophthalmic Ultrasound System is a non-invasive, active, diagnostic, ultrasound biomicroscopy device intended for use in ophthalmic applications.The ultrasound probe with the system is a water path probe with 35 MHz transducer providing high resolution images. The VuPad B-Scan mode produces a live, two-dimensional image to facilitate the identification and measurement of ocular pathologies in the posterior chamber of the eye. The system is a stand-alone system that runs on a Windows 10 platform and may be networked for interface with electronic medical records systems and printers. The system is provided with the portable UBM tablet, water-path probe with 35 MHz transducer, built-in probe holder, foot switch and user manual.
SONOMED, INC.
VuPad UBM
In Commercial Distribution

  • 00896100002149 ()
U.580

  • Ophthalmic ultrasound imaging system
The current LifeChoice Activox Portable Oxygen Concentrator (Generator) is used on a prescriptive basis by patients who are diagnosed as requiring supplemental oxygen.The oxygen concentrator provides supplemental, high concentration oxygen to these patients. It is not life-supporting nor life-sustaining. It may be used continuously in a home, institution or travel environment.The LifeChoice Activox is also portable.
Inova Labs, Inc.
XYC100B-P4L
Not in Commercial Distribution

  • 08582530040029 ()
AOX-P4L-US(U)

  • Stationary oxygen concentrator
SolanaTrichomonas Assay
QUIDEL CORPORATION
Trichomonas Assay
In Commercial Distribution

  • 30014613336402 ()
M304.U

  • Trichomonas vaginalis nucleic acid IVD, kit, nucleic acid technique (NAT)
CHP BASIC G U PACK BCS
MEDLINE INDUSTRIES, INC.
DYNJ02671F
In Commercial Distribution

  • 10889942772834 ()
DYNJ02671F

  • General surgical procedure kit, non-medicated, single-use
CUSTOM PACK CB0M94R12 U OF IL
MEDTRONIC, INC.
CB0M94R12
In Commercial Distribution

  • 00643169904545 ()


  • Cardiopulmonary bypass system blood tubing set
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