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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 bracket with Infiniti Plus™ (12, 14, 16, 18GA) needle guides (2), Infiniti Plus™ (18, 20, 21/22, 25GA) needle guides (3), (14 x 91.5cm) CIV-Flex™ transducer covers (5) for use with Siemens VF16-5 transducers
CIVCO MEDICAL INSTRUMENTS CO., INC.
10787043
In Commercial Distribution

  • 00841436100465 ()
  • 20841436116255 ()

  • Length: 2.74 Inch
  • Height: 1.23 Inch
10787043

  • Ultrasound imaging system tracking positioner, reusable
Reusable non-sterile bracket with Infiniti Plus™ (12, 14, 16, 18GA) needle guides (2), Infiniti Plus™ (18, 20, 21/22, 25GA) needle guides (3), (14 x 147cm) CIV-Flex™ covers (5), gel and bands for use with Siemens HLX transducers
CIVCO MEDICAL INSTRUMENTS CO., INC.
11654277
In Commercial Distribution

  • 20841436123284 ()
  • 00841436123266 ()
11654277

  • Ultrasound imaging system tracking positioner, reusable
Reusable non-sterile bracket with Infiniti Plus™ (12, 14, 16, 18GA) needle guides (2), Infiniti Plus™ (18, 20, 21/22, 25GA) needle guides (3), (14 x 29.2cm) CIV-Flex™ wireless transducer covers (5) for use with Siemens L8-3 transducers
CIVCO MEDICAL INSTRUMENTS CO., INC.
11001906
In Commercial Distribution

  • 00841436100540 ()
  • 20841436115685 ()

  • Height: 1.25 Inch
  • Length: 2.98 Inch
11001906

  • Ultrasound imaging system tracking positioner, reusable
Reusable non-sterile bracket with Infiniti Plus™ (12, 14, 16, 18GA) needle guides (2), Infinity Plus™ (18, 20, 21/22, 25GA) needle guides (3), (14 x 29.2cm) CIV-Flex™ wireless transducer covers (5) for use with Siemens CH5-2 transducers
CIVCO MEDICAL INSTRUMENTS CO., INC.
11003205
In Commercial Distribution

  • 20841436118907 ()
  • 00841436119047 ()

  • Height: 1.2 Inch
  • Length: 3.8 Inch
11003205

  • Ultrasound imaging system tracking positioner, reusable
Bilateral Four Channel Phased Array CAROTIDS COIL for bilateral MRI proton imaging of the carotids bifurcation. The Carotids Coil enables sub-millimeter resolution of the carotids lumen, vessel walls and atherosclerotic plaques. Compatible with Siemens MAGNETOM Trio, Verio, Skyra and Prisma 3T scanners.
Machnet B.V.
PACC-ST30
In Commercial Distribution

  • B318PACCST301 ()
PACC-ST30

  • MRI system coil, radio-frequency
Bilateral Four Channel Phased Array CAROTIDS COIL for bilateral MRI proton imaging of the carotids bifurcation. The Carotids Coil enables sub-millimeter resolution of the carotids lumen, vessel walls and atherosclerotic plaques. Compatible with Siemens MAGNETOM Symphony, Sonata, Avanto and Espree 1.5T scanners.
Machnet B.V.
PACC-SS15
In Commercial Distribution

  • B318PACCSS151 ()
PACC-SS15

  • MRI system coil, radio-frequency
Sterile Disposable Endocavity Needle Guide for use with Siemens EC9-4 (Acuson NX2™, NX3™, NX3™ Elite, P500™, X150™, X300™ & Sonoline G40™ Ultrasound Systems), EV9-4 (Sonoline G40™ & Acuson X150™ & X300™ Ultrasound Systems) Ultrasound Transducers
PROTEK MEDICAL PRODUCTS, INC.
5480
In Commercial Distribution

  • 10841912105745 ()
  • 00841912105748 ()
5480

  • Needle guide, single-use
Non-sterile (2 x 14cm) endocavity balloon for use with B-K Medical 8658 (8558) and 8848, Best® Sonalis™, GE Healthcare ERB, Hitachi Aloka Medical EUP-U533, UST 672.5/7.5, Siemens Endo-P II (on SONOLINE Adara/Prima ultrasound system) and Terason 8B48 transducers
CIVCO MEDICAL INSTRUMENTS CO., INC.
H46222LR
Not in Commercial Distribution

  • 00841436109079 ()
  • 80841436109075 ()

  • Lumen/Inner Diameter: 0.83 Inch
  • Length: 7.5 Inch
H46222LR

  • Body-orifice ultrasound imaging transducer cover, image-enhancement
No Description
THE BINDING SITE GROUP LIMITED
NK008.T
Not in Commercial Distribution

  • 05051700007764 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry
No Description
THE BINDING SITE GROUP LIMITED
LK043.T
Not in Commercial Distribution

  • 05051700006514 ()


  • Beta-2-microglobulin IVD, kit, nephelometry/turbidimetry
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