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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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M300 OvuCore Starter Pack - M026 OvuCore Vaginal Sensor and M032 OvuSense App
VIO HEALTHTECH LIMITED
M300
In Commercial Distribution

  • 05060508530039 ()


  • Thermometric fertility analyser
Ear thermometer with bluetooth which transmits data to app on mobile phone
Masena Invest B.V.
ET-624BT
In Commercial Distribution

  • 08719481720193 ()


  • Intermittent electronic patient thermometer
Robot Arm Interface instrument Rosa 3.0 instrument ROSA One spine app 3.1
MEDTECH
ROSA3-048A
Not in Commercial Distribution

  • 03760244030436 ()
ROSAS00126

  • Neurological stereotactic surgery system
  • Multi-purpose stereotactic surgery system
Pressure PreventionGroup 1 Surfaces Product Description: APP Pad Only, 1/ea, RTL
Drive Devilbiss Healthcare
14003
In Commercial Distribution

  • 50822383103742 ()
  • 00822383103747 ()


  • Alternating-pressure inflator
  • Alternating-pressure bed mattress overlay, reusable
  • Alternating-pressure bed mattress overlay system
RIGID ENDOSCOPIC AEROSOL APP. 5MM DIA X 40CM (16 IN) 1:1
Micromedics, Inc.
800-0217
In Commercial Distribution

  • 00815634020283 ()
  • 10815634020280 ()
  • 20815634020287 ()


  • Open-surgery adhesive/sealant applicator, dual-channel
4297-481 Unitek™ Nitinol Classic Standard Form U .019x.025 U/Use 10/Pk
3M UNITEK CORPORATION
4297-481
In Commercial Distribution

  • 80652221080185 ()
  • 00652221080189 ()
4297-481

  • Orthodontic archwire
Votion 022 MC(0T) U/L 5x5, OS Pad U/L 4/5 SPK
ORTHO TECHNOLOGY, INC.
350-22-2060
In Commercial Distribution

  • 00190730008176 ()


  • Orthodontic bracket, metal
Votion 018 MC(0T) U/L 5x5, OS Pad U/L 4/5 SPK
ORTHO TECHNOLOGY, INC.
350-21-2060
Not in Commercial Distribution

  • 00190730007605 ()


  • Orthodontic bracket, metal
BACKBITER ROTATING CURVED UP
JEDMED INSTRUMENT COMPANY
54-2999 U
In Commercial Distribution

  • M633542999U0 ()
54-2999 U

  • Surgical soft-tissue manipulation forceps, alligator, reusable
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
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
SolanaTrichomonas Assay
QUIDEL CORPORATION
Trichomonas Assay
In Commercial Distribution

  • 30014613336402 ()
M304.U

  • Trichomonas vaginalis nucleic acid IVD, kit, nucleic acid technique (NAT)
Lamineer Tip Spatula & Knife Edge Assortment Pack - 20/Pack - Diamond Coated with Safe Side - LTA-15, LTA-30, LTA-39 x2, LTA-50 x2, LTA-75, LTA-100, LTA-150, LTA-S15, LTA-S30, LTA-S36 x2, LTA-S50 x2, LTA-S75, LTA-S100, LTA-S150, LTA-C50, LTA-E50
Dentatus AB
LTA/U
In Commercial Distribution

  • 07350081490485 ()
LTA/U

  • Dental abrasive disk, reusable
ROTATING PUNCH SM CURVED UP
Bausch & Lomb Incorporated
N2921 U
In Commercial Distribution

  • 00757770508624 ()
N2921 U

  • ENT soft-tissue cutting forceps
PEDIATRIC PUNCH UPSDE BACK CUT
Bausch & Lomb Incorporated
N2918 U
In Commercial Distribution

  • 00757770508563 ()
N2918 U

  • Craniofacial rongeur, reusable
CIRCULAR CUT PUNCH UPTRN 3.5M
Bausch & Lomb Incorporated
N2922 U
In Commercial Distribution

  • 00757770508716 ()
N2922 U

  • ENT soft-tissue cutting forceps
LM Inicia DTS U, Intrasulcular knife
LM-Dental
171-172ESTU
In Commercial Distribution

  • 06438311707839 ()


  • Periodontal knife
LM Tunella DTS U, Tunneling knife
LM-Dental
175-177ESTU
In Commercial Distribution

  • 06438311707624 ()


  • Periodontal knife
LM Build-up Base DD DTS U
LM-Dental
485-707DDESTU
In Commercial Distribution

  • 06438311707464 ()


  • Manual dental burnisher, reusable
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