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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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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 - 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 - 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

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 - 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 - 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

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

STOP VX2 MODEL U - 07290016586626

No Description
POLLOGEN LTD
STOP VX2 MODEL U
In Commercial Distribution

  • 07290016586626 ()
34690000BK-US

  • Multi-modality skin contouring system

STOP VX MODEL U - 07290016586442

No Description
POLLOGEN LTD
STOP U MODEL UXV
In Commercial Distribution

  • 07290016586442 ()
34650000BP-US

  • Multi-modality skin contouring system

Ultra DC Package U - 00813830023190

No Description
ACCUTRON, INC.
46500-US
In Commercial Distribution

  • 00813830023190 ()
46500-US

  • Oxygen/air/nitrous oxide breathing gas mixer

Ultra PC % Package U - 00813830022643

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

  • 00813830022643 ()
36500-US

  • Oxygen/air/nitrous oxide breathing gas mixer

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

cobas U Calibration Strip - 04015630932276

No Description
Roche Diagnostics GmbH
06390579001
In Commercial Distribution

  • 04015630932276 ()
06390579001

  • Multiple-type clinical chemistry analyte profile IVD, calibrator

NEO 2401.U/1 - 04035479188399

No Description
BIOTRONIK SE & Co. KG
492817
In Commercial Distribution

  • 04035479188399 ()
492817

  • Cardiac pulse generator programmer

RETRACTOR U OF MINNESOTA - D9281055300

No Description
W.H. Holden, Inc.
10-5530
In Commercial Distribution

  • D9281055300 ()


  • Dental cheek retractor, professional, reusable

Atellica IM Calibrator U - 00630414598468

Calibrator U - Atellica IM - CAL (2PK) 2 x 2 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
10995519
In Commercial Distribution

  • 00630414598468 ()
  • 00630414190907 ()
10995519

  • Myoglobin IVD, calibrator

CUSTOM U JOINT DRIVER - 00889024586956

No Description
Zimmer, Inc.
SSI005667
In Commercial Distribution

  • 00889024586956 ()
SSI005667

  • Surgical instrument handle, non-torque-limiting

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

STA® - Desorb U - 13607450009757

No Description
DIAGNOSTICA STAGO
00975
In Commercial Distribution

  • 03607450009750 ()
  • 13607450009757 ()


  • Buffered wash solution IVD

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

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

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

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

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

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

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

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

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

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

Solana - 30014613336402

SolanaTrichomonas Assay
QUIDEL CORPORATION
Trichomonas Assay
In Commercial Distribution

  • 30014613336402 ()
M304.U

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

Integra® Miltex® - 10381780507017

Contra Angle, Standard U, 20,000 RPM
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
75-15
Not in Commercial Distribution

  • H834750150 ()
  • 10381780507017 ()
75-15

  • Dental laboratory drilling system handpiece

Integra® Miltex® - 10381780506997

Contra Angle, Standard U, 20,000 RPM
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
75-12
Not in Commercial Distribution

  • H83475120 ()
  • 10381780506997 ()
75-12

  • Dental laboratory drilling system handpiece

NORDENT MANUFACTURING INC - 00840018610798

SE SCALER U OF TEXAS 106
NORDENT MANUFACTURING INC
SCUT106
In Commercial Distribution

  • 00840018610798 ()


  • Manual dental scaler, reusable

NORDENT MANUFACTURING INC - 00840018610781

SE SCALERS U OF TEXAS 103
NORDENT MANUFACTURING INC
SCUT103
In Commercial Distribution

  • 00840018610781 ()


  • Manual dental scaler, reusable

NORDENT MANUFACTURING INC - 00840018606494

SE PROBE U OF MICH O
NORDENT MANUFACTURING INC
PUMO
In Commercial Distribution

  • 00840018606494 ()


  • Periodontal probe, reusable

TRUMPF MEDICAL - 00887761994935

Pad pelvic extension H B U
Baxter Medical Systems GmbH + Co. KG
1909819
Not in Commercial Distribution

  • 00887761994935 ()


  • Operating table patient pressure distribution pad, reusable

TRUMPF MEDICAL - 00887761993204

OR table top MR Neuro U
Baxter Medical Systems GmbH + Co. KG
2064888
Not in Commercial Distribution

  • 00887761993204 ()


  • Universal operating table, electromechanical

TRUMPF MEDICAL - 00887761993129

Floor mounting column TS 7500 U
Baxter Medical Systems GmbH + Co. KG
1730732
Not in Commercial Distribution

  • 00887761993129 ()


  • Electromechanical operating table base

TRUMPF MEDICAL - 00887761991781

Upper back section H V U
Baxter Medical Systems GmbH + Co. KG
1909813
Not in Commercial Distribution

  • 00887761991781 ()


  • Operating table orthopaedic extension, non-powered

Trumpf Medical - 00887761991125

OR table top U24 U V
Baxter Medical Systems GmbH + Co. KG
1846381
Not in Commercial Distribution

  • 00887761991125 ()


  • Universal operating table, electromechanical

TRUMPF MEDICAL - 00887761989719

Operating table TruSystem 7000 U dV
Baxter Medical Systems GmbH + Co. KG
1723633
Not in Commercial Distribution

  • 00887761989719 ()


  • Universal operating table, electromechanical

TRUMPF MEDICAL - 00887761987227

Widening segment seat section TITAN U
Baxter Medical Systems GmbH + Co. KG
1255814
Not in Commercial Distribution

  • 00887761987227 ()


  • Patient positioning vacuum pad

Trumpf Medical - 00887761984646

X-Ray Top Set PST 500 U
Baxter Medical Systems GmbH + Co. KG
2072443
Not in Commercial Distribution

  • 00887761984646 ()


  • X-ray film cassette holder
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