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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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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 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
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
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
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
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
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
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
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
No Description
AALTO SCIENTIFIC
K970M-5
In Commercial Distribution

  • B085K970M50 ()


  • Multiple-type clinical chemistry analyte profile IVD, control
No Description
Aktina Corp.
52-485
In Commercial Distribution

  • B365524850 ()


  • Radiation therapy beam block production plate
  • Radiation therapy beam block production hot-wire
No Description
ALIMED, INC.
910412ZBW
In Commercial Distribution

  • 00733657259148 ()
2970011559

  • Operating table mattress, basic
No Description
ALIMED, INC.
910410ZBW
In Commercial Distribution

  • 00733657259124 ()
2970011557

  • Operating table mattress, basic
A comprehensive cellular component and chemistry analyte urinalysis control designed specifically for the Siemens CLINITEK Atlas® and Sysmex® UF-1000i™ combined urinalysis system. Contains 1 vial each of L-PC,PCM & NC.
STRECK, INC.
218991
In Commercial Distribution

  • 00844509001935 ()

  • Total Volume: 120 Milliliter
218991

  • Urine sediment IVD, control
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) and Samsung Medison EA2-11B transducers
CIVCO MEDICAL INSTRUMENTS CO., INC.
676-133, 676-133-5
In Commercial Distribution

  • 00841436107310 ()
  • 10841436107317 ()
  • 00841436107303 ()

  • Width: 1.5 Inch
  • Length: 6.4 Inch
676-133, 676-133-5

  • Needle guide, single-use
Sterile Disposable Endocavity Needle Guide for use with Esaote EC123, EC1123, SE3123, SE3133, TRT12 & IVT12, GE Healthcare IC5-9-RS & IC5-9W-RS, Philips E6509, Siemens BE9-4, Samsung Medison BCC4-9, Pie Medical C7-4R8TRD and Terason 8EC4 Ultrasound Transducers
PROTEK MEDICAL PRODUCTS, INC.
5565
In Commercial Distribution

  • 10841912106612 ()
  • 00841912106615 ()
5565

  • Needle guide, single-use
No Description
Noras MRI products GmbH
01
In Commercial Distribution

  • 04251269200441 ()
114786

  • MRI system coil, radio-frequency
No Description
Noras MRI products GmbH
01
In Commercial Distribution

  • 04251269204678 ()
114785

  • MRI system coil, radio-frequency
No Description
ALIMED, INC.
910408ZBW
In Commercial Distribution

  • 00733657259100 ()
2970011552

  • Operating table mattress, basic
No Description
ALIMED, INC.
910407ZBW
In Commercial Distribution

  • 00733657259094 ()
2970011551

  • Operating table mattress, basic
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