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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U OF UTAH VASCULAR TRAY
Cardinal Health 200, LLC
SCV56VT198
In Commercial Distribution

  • 50195594644626 ()
  • 10195594644628 ()
SCV56VT198

  • Cardiothoracic surgical procedure kit, medicated, single-use
U OF UTAH INTERVENTIONAL TRAY
Cardinal Health 200, LLC
SAN56PI121
In Commercial Distribution

  • 50195594679741 ()
  • 10195594679743 ()
SAN56PI121

  • General surgical procedure kit, non-medicated, single-use
U OF UTAH VASCULAR TRAY
Cardinal Health 200, LLC
SCV56VT197
In Commercial Distribution

  • 50195594586889 ()
  • 10195594586881 ()
SCV56VT197

  • Cardiothoracic surgical procedure kit, medicated, single-use
U BAR HOLY SPIRIT PACK
Cardinal Health 200, LLC
SOP7AUBHSC
In Commercial Distribution

  • 50197106633678 ()
  • 10197106633670 ()
SOP7AUBHSC

  • Orthopaedic surgical procedure kit, medicated
KIT,MINOR U BAR MDST
Cardinal Health 200, LLC
POCGUBCPA
In Commercial Distribution

  • 50197106638789 ()
  • 10197106638781 ()
POCGUBCPA

  • Orthopaedic surgical procedure kit, non-medicated, single-use
Upper Body U Drape_77inx110in_Non-Sterile_22EA/CS
GRI Medical & Electronic Technology Co., Ltd.
i80-09188
In Commercial Distribution

  • 06931918171596 ()
  • 16931918171593 ()


  • Patient surgical drape, single-use
U OF UTAH INTERVENTIONAL TRAY
Cardinal Health 200, LLC
SAN56PI118
In Commercial Distribution

  • 50195594577238 ()
  • 10195594577230 ()
SAN56PI118

  • General surgical procedure kit, non-medicated, single-use
U OF UTAH INTERVENTIONAL TRAY
Cardinal Health 200, LLC
SAN56PI119
In Commercial Distribution

  • 50195594599964 ()
  • 10195594599966 ()
SAN56PI119

  • General surgical procedure kit, non-medicated, single-use
Pinnacle 018 Roth U/L 5x5, OS Pad U/L 4/5 SPK
ORTHO TECHNOLOGY, INC.
360-91-2020
Not in Commercial Distribution

  • 00190730010483 ()


  • Orthodontic bracket, metal
Pinnacle 022 MC U/L 5x5, OS Pad U/L 4/5 SPK
ORTHO TECHNOLOGY, INC.
360-22-2020
Not in Commercial Distribution

  • 00190730009944 ()


  • Orthodontic bracket, metal
Votion 022 Roth U/L 5x5, OS Pad U/L 4/5 SPK
ORTHO TECHNOLOGY, INC.
350-92-2020
In Commercial Distribution

  • 00190730009081 ()


  • Orthodontic bracket, metal
Votion 022 MC U/L 5x5, OS Pad U/L 4/5 SPK
ORTHO TECHNOLOGY, INC.
350-22-2020
In Commercial Distribution

  • 00190730008114 ()


  • Orthodontic bracket, metal
Pinnacle 022 Roth U/L 5x5, OS Pad U/L 4/5 SPK
ORTHO TECHNOLOGY, INC.
360-92-2020
In Commercial Distribution

  • 00190730010919 ()


  • Orthodontic bracket, metal
Votion 018 Roth U/L 5x5, OS Pad U/L 4/5 SPK
ORTHO TECHNOLOGY, INC.
350-91-2020
In Commercial Distribution

  • 00190730008657 ()


  • Orthodontic bracket, metal
Votion 018 MC U/L 5x5, OS Pad U/L 4/5 SPK
ORTHO TECHNOLOGY, INC.
350-21-2020
Not in Commercial Distribution

  • 00190730007544 ()


  • Orthodontic bracket, metal
+ 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
The NuBOOM/DOCS system is an equipment management and audio/video integration system that is installed in health care facilities where video-assisted procedures are performed. The NuBOOM/DOCS system is used by trained health care personnel to route video signals from medical equipment (i.e., endoscopic cameras, C-arms, ultrasound, PACS) to flat-panel monitors for display during procedures. The NuBOOM/DOCS system consists of two major components: an equipment management subsystem and a video integration subsystem. The equipment management subsystem—called the NuBOOM—is a metal superstructure (cabinet) that is anchored to the facility floor. The cabinet provides an attachment point for booms, which support adjustable arms with flat-panel monitors, and shelves for storage of medical equipment. The booms and spring arms can be moved to allow the most ergonomic placement of the flat-panel monitors. The equipment management component of the NuBOOM/DOCS system provides health care staff with an adjustable system that can be configured to the needs of each procedure.
Cv Medical, LLC
U
In Commercial Distribution

  • 00860001554526 ()


  • Medical image management system
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
It is intended for use in correcting improper posture, such as hunching or slouching, and improving overall body alignment. It is suitable for both adults and children who need assistance in maintaining proper posture.
Cofoe Medical Technology Co.,Ltd
U+
In Commercial Distribution

  • 06950715501580 ()


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

  • 05060508530039 ()


  • Thermometric fertility analyser
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
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
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
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
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
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
SolanaTrichomonas Assay
QUIDEL CORPORATION
Trichomonas Assay
In Commercial Distribution

  • 30014613336402 ()
M304.U

  • Trichomonas vaginalis nucleic acid IVD, kit, nucleic acid technique (NAT)
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
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
Hoe Scaler, lateral DTS U, Periodontics
LM-Dental
134-135ESTU
In Commercial Distribution

  • 06438311011554 ()


  • Periodontal hoe
Mirror handle JM DTS U, Diagnostics
LM-Dental
25-473ESTU
In Commercial Distribution

  • 06438311000329 ()


  • Dental mirror, reusable
Sickle LM-Laplander DTS U, Scaler, Periodontics
LM-Dental
148-149ESTU
In Commercial Distribution

  • 06438311011493 ()


  • Manual dental scaler, reusable
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