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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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Ultra PC % Package U - 00813830022643

No Description
ACCUTRON, INC.
36500-US
In Commercial Distribution

  • 00813830022643 ()
36500-US

  • Oxygen/air/nitrous oxide breathing gas mixer

Small U Head Cushions - B525CO020

No Description
Octostop Inc
CO-02
In Commercial Distribution

  • B525CO020 ()


  • Radiological whole-body positioner

Large U Head Cushions - B525CO010

No Description
Octostop Inc
CO-01
In Commercial Distribution

  • B525CO010 ()


  • Radiological whole-body positioner

Symmetry U. S. Pattern - 00887482049372

Symmetry® Forceps, U.S Pattern Tube Occluding Forceps, 6 in
SYMMETRY SURGICAL INC.
17-7280
In Commercial Distribution

  • 00887482049372 ()

  • Length: 6 Inch
17-7280

  • Dressing/utility forceps, scissors-like, reusable

Hyaluronidase 80 U/mL - 20888937818899

Hyaluronidase 80 U/mL. 6x1.0 ml
Origio A/S
ART-4007-A
In Commercial Distribution

  • 20888937818899 ()
  • 00888937818918 ()


  • IVF medium

STOP VX2 MODEL U - 07290016586626

No Description
POLLOGEN LTD
STOP VX2 MODEL U
In Commercial Distribution

  • 07290016586626 ()
34690000BK-US

  • Multi-modality skin/body contouring system

STOP VX MODEL U - 07290016586442

No Description
POLLOGEN LTD
STOP U MODEL UXV
In Commercial Distribution

  • 07290016586442 ()
34650000BP-US

  • Multi-modality skin/body contouring system

Symmetry U. S. Pattern - 00887482057070

Symmetry® Forceps, U.S. Pattern Tube Occluding, (Heavy Jaw), 8 in
SYMMETRY SURGICAL INC.
17-7282
In Commercial Distribution

  • 00887482057070 ()

  • Length: 8 Inch
17-7282

  • Dressing/utility forceps, scissors-like, reusable

Symmetry U. S. Pattern - 00887482057063

Symmetry® Forceps, U.S. Pattern Tube Occluding, 7 1/4 in
SYMMETRY SURGICAL INC.
17-7281
In Commercial Distribution

  • 00887482057063 ()

  • Length: 7.25 Inch
17-7281

  • Dressing/utility forceps, scissors-like, reusable

Damon - 00889989080506

+ 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

Oertli® - 07630003902211

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

Pinnacle - 00190730010483

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

Votion - 00190730009081

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 - 00190730008657

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 - 00190730007544

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

Pinnacle - 00190730010919

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

Pinnacle - 00190730009944

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 - 00190730008114

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

NuBOOM - 00860001554526

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 - 16939550822163

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

Cofoe - 06950715501580

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

3M™ Unitek™ - 00652221080189

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 - 00190730007605

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

Votion - 00190730008176

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

OvuSense - 05060508530039

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

  • 05060508530039 ()


  • Thermometric fertility analyser

iProvèn - 08719481720193

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

DRIVEMEDICAL - 00822383103747

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

STERILE ROBOT ARM INTERFACE - 03760244030436

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

BIOMET - 00815634020283

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

JEDMED - M633542999U0

BACKBITER ROTATING CURVED UP
JEDMED INSTRUMENT COMPANY
54-2999 U
In Commercial Distribution

  • M633542999U0 ()
54-2999 U

  • Surgical soft-tissue manipulation forceps, alligator, reusable

VuMAX HD Ophthalmic Ultrasound System - 00896100002194

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

VuPad Ophthalmic Ultrasound System - 00896100002149

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

Lifechoice Activox P4L - 08582530040029

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 Tips - 07350081490485

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

Solana - 30014613336402

SolanaTrichomonas Assay
QUIDEL CORPORATION
Trichomonas Assay
In Commercial Distribution

  • 30014613336402 ()
M304.U

  • Trichomonas vaginalis nucleic acid IVD, kit, nucleic acid technique (NAT)

Bausch + Lomb - 00757770508624

ROTATING PUNCH SM CURVED UP
Bausch & Lomb Incorporated
N2921 U
In Commercial Distribution

  • 00757770508624 ()
N2921 U

  • ENT soft-tissue cutting forceps

Bausch + Lomb - 00757770508563

PEDIATRIC PUNCH UPSDE BACK CUT
Bausch & Lomb Incorporated
N2918 U
In Commercial Distribution

  • 00757770508563 ()
N2918 U

  • Craniofacial rongeur, reusable

Bausch + Lomb - 00757770508716

CIRCULAR CUT PUNCH UPTRN 3.5M
Bausch & Lomb Incorporated
N2922 U
In Commercial Distribution

  • 00757770508716 ()
N2922 U

  • ENT soft-tissue cutting forceps

NA - 04546540494733

U Series MIS Long Curved Attachment
STRYKER CORPORATION
5100010952
Not in Commercial Distribution

  • 04546540494733 ()
5100-010-952

  • Drilling power tool attachment, basic

NA - 04546540494726

U Series MIS Long Straight Attachment
STRYKER CORPORATION
5100010950
Not in Commercial Distribution

  • 04546540494726 ()
5100-010-950

  • Drilling power tool attachment, basic

NA - 04546540494719

U Series MIS Medium Curved Attachment
STRYKER CORPORATION
5100010922
Not in Commercial Distribution

  • 04546540494719 ()
5100-010-922

  • Drilling power tool attachment, basic

NA - 04546540494702

U Series MIS Medium Straight Attachment
STRYKER CORPORATION
5100010920
Not in Commercial Distribution

  • 04546540494702 ()
5100-010-920

  • Drilling power tool attachment, basic

Medline - 10080196739462

DRAPE,U/ SHT,SPLIT,PLAS,STERIL
MEDLINE INDUSTRIES, INC.
DYNJP2499
In Commercial Distribution

  • 40080196739463 ()
  • 10080196739462 ()

  • Length: 76 Inch
  • Width: 54 Inch
DYNJP2499

  • Patient surgical drape, single-use

Alpen - D661XU878KC0161

U SU DMND CURETTAGE 878K 16C
COLTENE/WHALEDENT INC
XU878KC016
Not in Commercial Distribution

  • D661XU878KC0161 ()
  • D661XU878KC0160 ()


  • Carbide dental bur, reusable

Alpen - D661XU878KC0121

U SU DMD MODBVLDCYLDR878K 12 C
COLTENE/WHALEDENT INC
XU878KC012
Not in Commercial Distribution

  • D661XU878KC0121 ()
  • D661XU878KC0120 ()


  • Carbide dental bur, reusable

CARDINAL HEALTH - 10888439303711

U S C T BIOPSY TRAY
Cardinal Health 200, LLC
MNU12BPS10
In Commercial Distribution

  • 50888439303719 ()
  • 10888439303711 ()
MNU12BPS10

  • General surgical procedure kit, medicated

CARDINAL HEALTH - 10888439273373

CUSTOM G U T S TRAY
Cardinal Health 200, LLC
32-1395B
In Commercial Distribution

  • 50888439273371 ()
  • 10888439273373 ()
32-1395B

  • General surgical procedure kit, medicated

NA - 04546540348432

U Series Elite Straight Long Attachment
STRYKER CORPORATION
5100010470
In Commercial Distribution

  • 04546540348432 ()
5100-010-470

  • Drilling power tool attachment, basic

NA - 04546540348418

U Series Elite Straight Medium Attachment
STRYKER CORPORATION
5100010450
In Commercial Distribution

  • 04546540348418 ()
5100-010-450

  • Drilling power tool attachment, basic

NA - 04546540074546

U Series Angled Long "AM" Attachment
STRYKER CORPORATION
5100010072
Not in Commercial Distribution

  • 04546540074546 ()
5100-010-072

  • Drilling power tool attachment, basic
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