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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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Disposable Needle Guides for use with Samsung EA2-11B; Siemens EC9-4, EV9-4(SONOLINE G40, X150, X300; Terason 8EC4A Ultrasound Transducers
JingFang Precision Medical Device(Shenzhen) Co., Ltd.
DE-021
In Commercial Distribution

  • 16971554725217 ()
  • 06971554725210 ()
DE-021

  • Needle guide, single-use
EXABLATE NEURO PATIENT TREATMENT KIT 1.5T SI w/PFK for 5 treatments for Siemens MR PFK package served ETO-sterile
INSIGHTEC LTD
SET001116 (w/ PFK) EXABLATE NEURO PATIENT TREATMENT KIT 1.5T SI
In Commercial Distribution

  • 07290019402183 ()
SET001116

  • Therapeutic oncological/gynaecological ultrasound system
EXABLATE NEURO PATIENT TREATMENT KIT 3.0T SI w/PFK for 1 treatment for Siemens MR PFK package served ETO-sterile
INSIGHTEC LTD
SET001113-SU (w/ PFK) EXABLATE NEURO PATIENT TREATMENT KIT 3.0T SI
In Commercial Distribution

  • 07290019402138 ()
SET001113-SU

  • Therapeutic oncological/gynaecological ultrasound system
EXABLATE NEURO PATIENT TREATMENT KIT 3.0T SI w/PFK for 5 treatments for Siemens MR PFK package served ETO-sterile
INSIGHTEC LTD
SET001113 (w/ PFK) EXABLATE NEURO PATIENT TREATMENT KIT 3.0T SI
In Commercial Distribution

  • 07290019402121 ()
SET001113

  • Therapeutic oncological/gynaecological ultrasound system
Reusable non-sterile bracket with Verza guides (5) and (14 x 91.5cm) CIV-Flex covers (5) for use with Siemens 7L2 transducers
CIVCO MEDICAL INSTRUMENTS CO., INC.
11506900
In Commercial Distribution

  • 00841436119474 ()
  • 20841436118884 ()
11506900

  • Ultrasound imaging system tracking positioner, reusable
EXABLATE NEURO PATIENT TREATMENT KIT 1.5T SI SU w/PFK for 1 treatment for Siemens MR PFK package served ETO-sterile
INSIGHTEC LTD
SET001116-SU (w/ PFK) EXABLATE NEURO PATIENT TREATMENT KIT 1.5T SI SU
In Commercial Distribution

  • 07290019402190 ()
SET001116-SU

  • Therapeutic oncological/gynaecological ultrasound system
Reusable non-sterile tracking bracket with (14 x 91.5cm) CIV-Flex™ covers (5), cleaning brushes (5) for use with Siemens 6C2 transducers
CIVCO MEDICAL INSTRUMENTS CO., INC.
10441190
In Commercial Distribution

  • 00841436100328 ()
  • 20841436117771 ()

  • Width: 1.17 Inch
  • Length: 3.48 Inch
10441190

  • Electromagnetic surgical navigation device tracking system
Reusable non-sterile tracking bracket with (14 x 91.5cm) CIV-Flex™ covers (5), cleaning brushes (5) for use with Siemens 4V1 transducers
CIVCO MEDICAL INSTRUMENTS CO., INC.
10441188
In Commercial Distribution

  • 00841436100304 ()
  • 20841436117382 ()

  • Height: 1.37 Inch
  • Length: 2.15 Inch
10441188

  • Electromagnetic surgical navigation device tracking system
Reusable non-sterile bracket with Verza guides (5) and (14 x 91.5cm) CIV-Flex covers (5) for use with Siemens Healtineers 13L4 transducers
CIVCO MEDICAL INSTRUMENTS CO., INC.
11502761
In Commercial Distribution

  • 20841436118877 ()
  • 00841436119023 ()

  • Width: 1.1 Inch
  • Length: 2.4 Inch
11502761

  • Ultrasound imaging system tracking positioner, reusable
for use with Siemens TXT or Proutra™ with Lok-Bar™, Prodigy™*2 Head Extension, rectangular extension, and storage rack
MEDTEC, INC.
MTIL6040
In Commercial Distribution

  • 00841439105344 ()
MTIL6040

  • Indexed-immobilization patient positioning system
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