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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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Biopsy Starter Kit - 00841436100045

Reusable non-sterile single-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm) CIV-Flex™ covers (5) and cleaning brushes (5) for use with Siemens CH6-2 transducers
CIVCO MEDICAL INSTRUMENTS CO., INC.
7472322
In Commercial Distribution

  • 00841436100045 ()
  • 20841436115883 ()

  • Height: 1.4 Inch
  • Length: 3.7 Inch
07472322

  • Ultrasound imaging system tracking positioner, reusable

Tracking Bracket Starter Kit - 00841436110655

Reusable non-sterile multi-angle tracking bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm) CIV-Flex™ covers (5), cleaning brushes (5) for use with Siemens 9L4 transducers
CIVCO MEDICAL INSTRUMENTS CO., INC.
11292182
In Commercial Distribution

  • 20841436115920 ()
  • 00841436110655 ()
11292182

  • Ultrasound imaging system tracking positioner, reusable

Biopsy Starter Kit - 00841436105576

Reusable non-sterile multi-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm) CIV-Flex™ covers (5) for use with Esaote CA123 and Siemens CA123 ultrasound transducers
CIVCO MEDICAL INSTRUMENTS CO., INC.
639-028
In Commercial Distribution

  • 00841436105576 ()
  • 20841436117504 ()

  • Height: 1.9 Inch
  • Length: 2.1 Inch
639-028

  • Ultrasound imaging system tracking positioner, reusable

Biopsy Starter Kit - 00841436100458

Reusable non-sterile multi-angle bracket with Ultra-Pro II™ Needle guides (5), (17.8 x 91.5cm) CIV-Flex™ covers (5) and cleaning brushes (5) for use with Siemens 7CF1 transducers
CIVCO MEDICAL INSTRUMENTS CO., INC.
10785723
Not in Commercial Distribution

  • 00841436100458 ()
  • 20841436117788 ()

  • Width: 2.14 Inch
  • Length: 1.8 Inch
10785723

  • Needle guide, single-use

Biopsy Bracket Starter Kit - 00841436100311

Reusable non-sterile single-angle tracking bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm) CIV-Flex™ covers (5), cleaning brushes (5) for use with Siemens 6C2 transducers
CIVCO MEDICAL INSTRUMENTS CO., INC.
10441189
In Commercial Distribution

  • 00841436100311 ()
  • 20841436116965 ()

  • Length: 3.69 Inch
  • Height: 1.42 Inch
10441189

  • Electromagnetic surgical navigation device tracking system

Tracking Bracket Starter Kit - 00841436100298

Reusable non-sterile multi-angle tracking bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm) CIV-Flex™ covers (5), cleaning brushes (5) for use with Siemens 4V1 transducers
CIVCO MEDICAL INSTRUMENTS CO., INC.
10441187
In Commercial Distribution

  • 00841436100298 ()
  • 20841436115975 ()

  • Length: 2.57 Inch
  • Height: 1.87 Inch
10441187

  • Electromagnetic surgical navigation device tracking system

NA - 15060797550814

Siemens Artis Zee UltraCare Replacement Table Pad Set. The UltraCare Series is a dense supportive foam, a cradling Visco foam top layer with a 4 way stretch covering.
David Scott Company
BB-SIE-ART-ZEE-UC
In Commercial Distribution

  • 15060797550814 ()

  • Length: 107 Inch
  • Width: 26 Inch
BB-SIE-ART-ZEE-UC

  • Operating table patient pressure distribution pad, reusable

Audit MicroControls Linearity FLQ ISE + Trigs for Siemens Dimension - B085K960M50

No Description
AALTO SCIENTIFIC
K960M-5
In Commercial Distribution

  • B085K960M50 ()


  • Multiple-type clinical chemistry analyte profile IVD, control

Audit MicroControls Linearity FLQ Anemia for Siemens Atellica/Centaur - B085K819M50

No Description
AALTO SCIENTIFIC
K819M-5
In Commercial Distribution

  • B085K819M50 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control

Audit MicroControls Linearity FD Tumor Markers Siemens Atellica/Centaur - B085K805M50

No Description
AALTO SCIENTIFIC
K805M-5
In Commercial Distribution

  • B085K805M50 ()


  • Multiple tissue-associated protein/tumour marker IVD, control

Audit MicroControls Linearity FD Cardiac Markers Siemens Atellica/Centaur - B085K804M50

No Description
AALTO SCIENTIFIC
K804M-5
In Commercial Distribution

  • B085K804M50 ()


  • Multiple cardiac marker IVD, control

Beam Block Tray, Lexan, Star Patter, Siemens Conv 600 - B36552600HL0

No Description
Aktina Corp.
52-600-HL
In Commercial Distribution

  • B36552600HL0 ()


  • Manual-aperture-control therapeutic x-ray system collimator, non-motorized

NORAS OR HEAD COIL Top Array Siemens 3T Refurbished - 04251269206849

The intended use of the NORAS OR head coil, is in conjunction with a Magnetic Resonance Scanner, the MR examination of the human brain just before, during and at the end of the brain surgery in the operating room. The coil can also be used as a standard diagnostic head coil for diagnostic examinations.
Noras MRI products GmbH
05
In Commercial Distribution

  • 04251269206849 ()
117816

  • MRI system coil, radio-frequency

NORAS OR HEAD COIL Bottom Array Siemens 3T Refurbished - 04251269206832

The intended use of the NORAS OR head coil, is in conjunction with a Magnetic Resonance Scanner, the MR examination of the human brain just before, during and at the end of the brain surgery in the operating room. The coil can also be used as a standard diagnostic head coil for diagnostic examinations.
Noras MRI products GmbH
04
In Commercial Distribution

  • 04251269206832 ()
117819

  • MRI system coil, radio-frequency

NORAS OR HEAD COIL Bottom Array Siemens 1.5T Refurbished - 04251269206825

The intended use of the NORAS OR head coil, is in conjunction with a Magnetic Resonance Scanner, the MR examination of the human brain just before, during and at the end of the brain surgery in the operating room. The coil can also be used as a standard diagnostic head coil for diagnostic examinations.
Noras MRI products GmbH
07
In Commercial Distribution

  • 04251269206825 ()
SI7121

  • MRI system coil, radio-frequency

NORAS OR HEAD COIL Top Array Siemens 1.5T Refurbished - 04251269206818

The intended use of the NORAS OR head coil, is in conjunction with a Magnetic Resonance Scanner, the MR examination of the human brain just before, during and at the end of the brain surgery in the operating room. The coil can also be used as a standard diagnostic head coil for diagnostic examinations.
Noras MRI products GmbH
09
In Commercial Distribution

  • 04251269206818 ()
SI7111

  • MRI system coil, radio-frequency

DxTx Medical 3T eCoil Imaging Device (FRU for Siemens) - 00850011472187

Ecoil ID - STID TIM 30 FRU - 8624855
DXTX MEDICAL INC
STID TIM 30 FRU
In Commercial Distribution

  • 00850011472187 ()


  • MRI system coil, radio-frequency

Reusable Template, Best Precision Stepper, 17 Gauge, Siemens Ultrasound - 00852656007380

The Reusable Template is used for assisting the physician in placement of the brachytherapy needles for prostate brachytherapy procedures.
Best Nomos
6029
In Commercial Distribution

  • 00852656007380 ()


  • Needle guide, reusable

Reusable Template, Best Precision Stepper, 18 Gauge, Siemens Ultrasound - 00852656007373

The Reusable Template is used for assisting the physician in placement of the brachytherapy needles for prostate brachytherapy procedures.
Best Nomos
6007
In Commercial Distribution

  • 00852656007373 ()


  • Needle guide, reusable

High Dose Rate Frame, Best Precision Stepper (Siemens Grid) - 00852656007267

The High Dose Rate Frame, when used in conjunction with a High Dose Rate Sandwich, is used for assisting the physician in placement of the brachytherapy needles for prostate brachytherapy procedures.
Best Nomos
6012
In Commercial Distribution

  • 00852656007267 ()


  • Needle guide, reusable

MAS anti-HBs Positive Control – For use with Siemens Assays - 00884883007383

No Description
Microgenics Corporation
10027482-U
In Commercial Distribution

  • 00884883007383 ()


  • Hepatitis B virus antigen/antibody marker IVD, control

TABLEPAD,SIEMENS HIQ,PFM CAT ERR SIZE IS 15X88 - 00733657237573

No Description
ALIMED, INC.
920765
In Commercial Distribution

  • 00733657237573 ()
2970011793

  • Operating table mattress, basic

IMAG PAD SIEMENS KOORDINATE ANGIO CC/SEAMLESS VIN TEAL - 00733657259117

No Description
ALIMED, INC.
910409ZBW
In Commercial Distribution

  • 00733657259117 ()
2970011553

  • Operating table mattress, basic

InnoFine - 06971554720864

Reusable Needle Guides for use with Siemens EC-10C5, EC9-4, EV9-4(ACUSON X500; SONOLINE G20, G50, G60 S); Samsung EC4-9IS, EC4-9ES, ER4-9ES; GE Healthcare IC5-9; Terason 8EC4(V) Ultrasound Transducers
JingFang Precision Medical Device(Shenzhen) Co., Ltd.
JEM-011
In Commercial Distribution

  • 06971554720864 ()


  • Needle guide, reusable

Quik-Clip™ Needle Guide - 10841436104835

Sterile needle guide with (14 x 61cm) flat-folded CIV-Flex™ cover for use with Siemens 4V2, V4, V2, L5, L7, C3, C366, C5, C544, 8L5, 6L3 and 5C2 transducers
CIVCO MEDICAL INSTRUMENTS CO., INC.
612-068
In Commercial Distribution

  • 00841436104838 ()
  • 10841436104835 ()

  • Width: 1.8 Inch
  • Length: 4.8 Inch
612-068

  • Needle guide, single-use

Needle Guide - 10841436104767

Sterile endocavity needle guide with (2 x 20cm) and (3.5 x 20cm) latex covers for use with Siemens EC7, EC9-4 (SONOLINE G20, G50, G60 S, X500) and EC-10C5 transducers
CIVCO MEDICAL INSTRUMENTS CO., INC.
612-051, 612-055
In Commercial Distribution

  • 00841436104784 ()
  • 00841436104760 ()
  • 10841436104767 ()

  • Height: 0.909 Inch
  • Length: 4.63 Inch
612-051, 612-055

  • Needle guide, single-use

Needle Guide - 10841436100219

Sterile endocavity needle guide with (2 x 20cm) and (3.5 x 20cm) latex covers for use with Siemens EC9-4 and EV9-4 (SONOLINE G40 and ACUSON X150, X300 systems) transducers
CIVCO MEDICAL INSTRUMENTS CO., INC.
10041822, 10041822-5
In Commercial Distribution

  • 00841436100212 ()
  • 10841436100219 ()
  • 00841436100205 ()

  • Height: 0.98 Inch
  • Length: 5.15 Inch
10041822, 10041822-5

  • Needle guide, single-use

Sterile Disposable Endocavity Needle Guide Kit - 00841912106349

Sterile Disposable Endocavity Needle Guide Kit for use with Canon-Toshiba PVF-621VT, PVF-641VT, PVF-651VT, PVG-601V, PWM-651VT, PVN-661VT, PVT-661VT & PVQ-641V, and Siemens EC9-4 (Acuson S2000 & Sonoline Antares Ultrasound Systems) Ultrasound Transducers
PROTEK MEDICAL PRODUCTS, INC.
5535
In Commercial Distribution

  • 10841912106346 ()
  • 00841912106349 ()
5535

  • Needle guide, single-use
  • Body-orifice ultrasound imaging transducer cover, basic

Biopsy Starter Kit - 00841436100250

Reusable non-sterile multi-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm) CIV-Flex™ covers (5) and cleaning brushes (5) for use with Siemens 8C3 HD transducers
CIVCO MEDICAL INSTRUMENTS CO., INC.
10136145
In Commercial Distribution

  • 00841436100250 ()
  • 20841436115944 ()

  • Length: 3.9 Inch
  • Height: 2.1 Inch
10136145

  • Ultrasound imaging system tracking positioner, reusable

Biopsy Starter Kit - 00841436100236

Reusable non-sterile multi-angle bracket with Ultra-Pro II™ Needle guides (5) (14 x 91.5cm) CIV-Flex™ covers (5) and cleaning brushes (5) for use with Siemens 18L6 HD transducers
CIVCO MEDICAL INSTRUMENTS CO., INC.
10044200
In Commercial Distribution

  • 00841436100236 ()
  • 20841436115586 ()

  • Length: 4.03 Inch
  • Height: 1.91 Inch
10044200

  • Ultrasound imaging system tracking positioner, reusable

Biopsy Starter Kit - 00841436100182

Reusable non-sterile multi-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm) CIV-Flex™ covers (5) and cleaning brushes (5) for use with Siemens 17L5 HD transducers
CIVCO MEDICAL INSTRUMENTS CO., INC.
10037928
In Commercial Distribution

  • 00841436100182 ()
  • 20841436117375 ()

  • Length: 3.98 Inch
  • Height: 1.95 Inch
10037928

  • Ultrasound imaging system tracking positioner, reusable

Biopsy Starter Kit - 00841436100113

Reusable non-sterile multi-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm) CIV-Flex™ covers (5), cleaning brushes (5) for use with Siemens 4C1 and 6C1HD transducers
CIVCO MEDICAL INSTRUMENTS CO., INC.
8260150
In Commercial Distribution

  • 00841436100113 ()
  • 20841436115401 ()

  • Length: 4.1 Inch
  • Height: 2 Inch
08260150

  • Ultrasound imaging system tracking positioner, reusable

Verza Guidance System - 00841436112260

Reusable non-sterile tracking bracket with Verza™ guides (5), (14 x 91.5cm) CIV-Flex™ covers (5), cleaning brushes (5) for use with Siemens Healthineers (Model No. 11291794) 5C1 transducers
CIVCO MEDICAL INSTRUMENTS CO., INC.
11287651
In Commercial Distribution

  • 20841436115777 ()
  • 00841436112260 ()
11287651

  • Ultrasound imaging system tracking positioner, reusable

IPPS™ Overlay - 00841439106624

For use with Posifix® thermoplastics with Prodigy™ Lok-Bar™ and supports (2) for Siemens MR Aera, Avanto fit, Prisma, Prisma fit, Skyra, Skyra fit, Spectra and Vida
MEDTEC, INC.
MTM3003
In Commercial Distribution

  • 00841439106624 ()
MTM3003

  • Indexed-immobilization patient positioning system

IPPS™ Overlay - 00841439106594

For use with Type-S™ thermoplastics with Prodigy™ Lok-Bar™ and supports (2) for Siemens MR Aera, Avanto fit, Prisma, Prisma fit, Skyra, Skyra fit, Spectra and Vida
MEDTEC, INC.
MTM3002
In Commercial Distribution

  • 00841439106594 ()
MTM3002

  • Indexed-immobilization patient positioning system

Biopsy Starter Kit - 00841436105521

Reusable non-sterile multi-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm) CIV-Flex™ covers (5) for use with Esaote LA435, SL2325 and Siemens LA435 ultrasound transducers
CIVCO MEDICAL INSTRUMENTS CO., INC.
639-023
In Commercial Distribution

  • 00841436105521 ()
  • 20841436117009 ()

  • Length: 3.3 Inch
  • Height: 1.8 Inch
639-023

  • Ultrasound imaging system tracking positioner, reusable

Biopsy Starter Kit - 00841436100052

Reusable non-sterile multi-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm) CIV-Flex™ covers (5), and cleaning brushes (5) for use with Siemens 4V1 and PH4-1 transducers
CIVCO MEDICAL INSTRUMENTS CO., INC.
7472330
In Commercial Distribution

  • 00841436100052 ()
  • 20841436115814 ()

  • Height: 1.9 Inch
  • Length: 2.7 Inch
07472330

  • Ultrasound imaging system tracking positioner, reusable

Biopsy Starter Kit - 00841436100038

Reusable non-sterile multi-angle bracket with Ultra-Pro II™ Needle guides (5), (17.8 x 91.5cm) CIV-Flex™ covers (5) and cleaning brushes (5) for use with Siemens CH4-1 and CH5-2 transducers
CIVCO MEDICAL INSTRUMENTS CO., INC.
7472314
In Commercial Distribution

  • 00841436100038 ()
  • 20841436115319 ()

  • Length: 4.1 Inch
  • Height: 2 Inch
07472314

  • Ultrasound imaging system tracking positioner, reusable

Biopsy Starter Kit - 00841436105477

Reusable non-sterile single-angle brackets with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm) CIV-Flex™ covers (5) for use with Esaote CA421, CA430, CA431 and Siemens CA431 ultrasound transducers
CIVCO MEDICAL INSTRUMENTS CO., INC.
639-018
In Commercial Distribution

  • 00841436105477 ()
  • 20841436117238 ()

  • Width: 1.16 Inch
  • Length: 1.54 Inch
639-018

  • Ultrasound imaging system tracking positioner, reusable

Biopsy Starter Kit - 00841436100670

Reusable non-sterile multi-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm) CIV-Flex™ cover (5), and cleaning brushes (5) for use with Siemens C5-2 and CX5-2 transducers
CIVCO MEDICAL INSTRUMENTS CO., INC.
4838723
In Commercial Distribution

  • 00841436100670 ()
  • 20841436117368 ()
04838723

  • Ultrasound imaging system tracking positioner, reusable

Biopsy Starter Kit - 00841436100373

Reusable non-sterile single-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm) CIV-Flex™ covers (5), and cleaning brushes (5) for use with Siemens 12L4 and VF12-4 transducers
CIVCO MEDICAL INSTRUMENTS CO., INC.
10658470
In Commercial Distribution

  • 00841436100373 ()
  • 20841436115951 ()

  • Length: 3.74 Inch
  • Height: 1.25 Inch
10658470

  • Ultrasound imaging system tracking positioner, reusable

Sterile Disposable Endocavity Needle Guide Kit - 00841912105328

Sterile Disposable Endocavity Needle Guide Kit for use with Toshiba PVF-621VT, PVF-641VT, PVF-651VT, PVG-601V, PVM-651VT, PVN-661VT, PVT-661VT & PVQ-641V and Siemens EC9-4 (Acuson S2000™ & Sonoline Antares™ Ultrasound Systems) Ultrasound Transducers
PROTEK MEDICAL PRODUCTS, INC.
5533
In Commercial Distribution

  • 10841912105325 ()
  • 00841912105328 ()
5533

  • Body-orifice ultrasound imaging transducer cover, basic
  • Needle guide, single-use

Biopsy Starter Kit - 00841436100069

Reusable non-sterile multi-angle bracket with Ultra-Pro II™ Needle guides (5), (17.8 x 91.5cm) CIV-Flex™ covers (5), and cleaning brushes (5) for use with Siemens 7CF2, C7F2 and C5F1 transducers
CIVCO MEDICAL INSTRUMENTS CO., INC.
7843159
In Commercial Distribution

  • 00841436100069 ()
  • 20841436117764 ()

  • Width: 2.3 Inch
  • Length: 2.8 Inch
07843159

  • Ultrasound imaging system tracking positioner, reusable

Biopsy Starter Kit - 00841436100694

Reusable non-sterile single-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm) CIV-Flex™ covers (5), and cleaning brushes (5) for use with Siemens 14L5, VF13-5 and VFX13-5 transducers
CIVCO MEDICAL INSTRUMENTS CO., INC.
4838756
In Commercial Distribution

  • 00841436100694 ()
  • 20841436116378 ()
04838756

  • Ultrasound imaging system tracking positioner, reusable

Tracking Bracket Starter Kit - 00841436100274

Reusable non-sterile multi-angle tracking bracket with Ultra-Pro II™ Needle guides (5), (17.8 x 91.5cm) CIV-Flex™ covers (5), cleaning brushes (5) for use with Siemens 4C1 and 6C1 HD transducers
CIVCO MEDICAL INSTRUMENTS CO., INC.
10441183
In Commercial Distribution

  • 00841436100274 ()
  • 20841436115746 ()

  • Height: 1.99 Inch
  • Length: 4.04 Inch
10441183

  • Electromagnetic surgical navigation device tracking system

Master Treatment Kit for 3.0T (SIEMENS) Type 1.1 NonCE/FDA - 07290015461900

A Kit for 10 Neuro treatments (Master Treatment Kit for 3.0T (SIEMENS) Type 1.1 NonCE/FDA) Kit content: Part Description SET001047 EXABLATE NEURO PATIENT TREATMENT KIT 3.0T SI (5) X 2 units
INSIGHTEC LTD
SET001104 Master Treatment Kit for 3.0T (SIEMENS) Type 1.1 NonCE/FDA
In Commercial Distribution

  • 07290015461900 ()
SET001104

  • Therapeutic oncological/gynaecological ultrasound system

Master Treatment Kit for 1.5T (SIEMENS) Type 1.1 NonCE/FDA - 07290015461894

A Kit for 10 Neuro treatment (Master Treatment Kit for 1.5T (SIEMENS) Type 1.1 NonCE/FDA). Kit content: Part Description SET001046 EXABLATE NEURO PATIENT TREATMENT KIT 1.5T SI (5) X 2 units
INSIGHTEC LTD
SET001103 Master Treatment Kit for 1.5T (SIEMENS) Type 1.1 NonCE/FDA
In Commercial Distribution

  • 07290015461894 ()
SET001103

  • Therapeutic oncological/gynaecological ultrasound system

Biopsy Starter Kit - 00841436105514

Reusable non-sterile multi-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm) CIV-Flex™ covers (5) for use with Esaote LA522, LA523, LA532 and Siemens LA523 and LA522E ultrasound transducers
CIVCO MEDICAL INSTRUMENTS CO., INC.
639-022
In Commercial Distribution

  • 00841436105514 ()
  • 20841436116675 ()

  • Height: 1.95 Inch
  • Length: 3.77 Inch
639-022

  • Ultrasound imaging system tracking positioner, reusable

Biopsy Starter Kit - 00841436100687

Reusable non-sterile multi-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm) CIV-Flex™ covers (5), and cleaning brushes (5) for use with Siemens 9L4, VF10-5, VF7-3, and VFX9-4 transducers
CIVCO MEDICAL INSTRUMENTS CO., INC.
4838749
In Commercial Distribution

  • 00841436100687 ()
  • 20841436115425 ()
04838749

  • Ultrasound imaging system tracking positioner, reusable

Audit MicroControls Linearity FLQ Special Diabetes for Siemens Atellica/Centaur - B085K970M50

No Description
AALTO SCIENTIFIC
K970M-5
In Commercial Distribution

  • B085K970M50 ()


  • Multiple-type clinical chemistry analyte profile IVD, control
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