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 tracking bracket with (5 tapered to 1.9 × 32cm) NeoGuard ™ covers (5) and cleaning brushes (5) for use with Siemens MC9-4 tranducers
CIVCO MEDICAL INSTRUMENTS CO., INC.
676-189
In Commercial Distribution

  • 00841436110945 ()
  • 20841436117399 ()

  • Width: 1.9 Inch
  • Length: 2.1 Inch
676-189

  • Electromagnetic surgical navigation device tracking system
Reusable non-sterile single-angle bracket with AccuSITE needle guides (5), (14 x 29.2cm) CIV-Flex™ wireless transducer covers (5) for use with Siemens L13-5 transducers
CIVCO MEDICAL INSTRUMENTS CO., INC.
11001907
In Commercial Distribution

  • 00841436100557 ()
  • 20841436115722 ()

  • Width: 1.3 Inch
  • Length: 2.54 Inch
11001907

  • Ultrasound imaging system tracking positioner, reusable
Reusable non-sterile tracking bracket with (17.8 x 147cm) CIV-Flex™ covers (5), cleaning brushes (5) for use with Siemens 4C1 and 6C1 HD transducers
CIVCO MEDICAL INSTRUMENTS CO., INC.
10441184
In Commercial Distribution

  • 00841436100281 ()
  • 20841436114138 ()

  • Length: 3.5 Inch
  • Width: 1.7 Inch
10441184

  • Electromagnetic surgical navigation device tracking system
Reusable non-sterile endocavity needle guide with cleaning brushes (5) for use with Siemens EC9-4 and EV9-4 (SONOLINE G40 and ACUSON X150, X300 systems) transducers
CIVCO MEDICAL INSTRUMENTS CO., INC.
10041823
In Commercial Distribution

  • 00841436100229 ()
  • 20841436114121 ()

  • Length: 5.14 Inch
  • Height: 1.51 Inch
10041823

  • Needle guide, reusable
Disposable Needle Guides Kit for endocavity biopsy, contents: Needle guide use with Siemens EV10-5, EC10-5w ultrasound transducers; 20g gel; 5x30cm latex cover, rubber bands.
JingFang Precision Medical Device(Shenzhen) Co., Ltd.
DEK-028
In Commercial Distribution

  • 16971554726580 ()
  • 06971554726583 ()
10658

  • Needle guide, single-use
Disposable Needle Guides for use with SuperSonic SE12-3; Siemens EC-10C5, EC9-4(ACUSON X500;SONOLINE G20, G50, G60S), EV9-4(ACUSON X500); ECM E610A Ultrasound Transducers
JingFang Precision Medical Device(Shenzhen) Co., Ltd.
DE-020
In Commercial Distribution

  • 16971554725200 ()
  • 06971554725203 ()
DE-020

  • Needle guide, single-use
Sterile endocavity needle guide with (2.6 x 20cm) and (3.5 x 20cm) latex covers for use with Esaote EC1123, SE3123 and Siemens EC1123 ultrasound transducers
CIVCO MEDICAL INSTRUMENTS CO., INC.
639-013, 639-013-5
In Commercial Distribution

  • 00841436105439 ()
  • 10841436105436 ()
  • 00841436105422 ()

  • Length: 5.48 Inch
  • Height: 0.97 Inch
639-013, 639-013-5

  • Needle guide, single-use
Sterile needle guide (barrel inserts only) for use with Siemens 4V2, 5C2, 6L3, 8L5, C3, C5, C366, C544, L5, L7, L582, V2 and V4 transducers
CIVCO MEDICAL INSTRUMENTS CO., INC.
612-062
In Commercial Distribution

  • 00841436104821 ()
  • 10841436104828 ()

  • Width: 1.8 Inch
  • Length: 4.8 Inch
612-062

  • Needle guide, single-use
Sterile needle guide with (5 x 30cm) latex cover for use with Siemens 4V2, V4, V2, L5, L7, C5, C544, 8L5, 6L3 and 5C2 transducers
CIVCO MEDICAL INSTRUMENTS CO., INC.
612-058
In Commercial Distribution

  • 00841436104807 ()
  • 10841436104804 ()

  • Width: 1.8 Inch
  • Length: 4.8 Inch
612-058

  • Needle guide, single-use
Reusable non-sterile tracking bracket with Verza™ guides (5), (14x91.5cm) CIV-Flex™ covers (5), and cleaning brushes (5) for use with Siemens Healthineer 9C2 transducers
CIVCO MEDICAL INSTRUMENTS CO., INC.
11504341
In Commercial Distribution

  • 20841436121297 ()
  • 00841436121613 ()
11504341

  • Ultrasound imaging system tracking positioner, reusable
Reusable non-sterile tracking bracket with Verza™ guides (5) and (14x91.5cm) CIV-Flex™ covers (5), and cleaning brushes for use with Siemens Healthineers 15L4-2 transducers
CIVCO MEDICAL INSTRUMENTS CO., INC.
11508588
In Commercial Distribution

  • 00841436120241 ()
11508588

  • Electromagnetic surgical navigation device tracking system
No Description
Noras MRI products GmbH
03
In Commercial Distribution

  • 04251269200380 ()
117816

  • MRI system coil, radio-frequency
No Description
Brainlab AG
19168
Not in Commercial Distribution

  • 04056481140588 ()
19168

  • Robotic surgical navigation system
No Description
Brainlab AG
41860-12
Not in Commercial Distribution

  • 04056481003135 ()
41860-12

  • Robotic surgical navigation system
"INTERFACE DEVICE, 3.0T TRIO TIM (60727587)"
BAYER MEDICAL CARE INC.
STID TIM 30
In Commercial Distribution

  • 00616258009025 ()
STID TIM 30

  • MRI system coil, radio-frequency
Ecoil ID - FID SYM FRU
DXTX MEDICAL INC
FID SYM FRU
In Commercial Distribution

  • 00850011472217 ()


  • MRI system coil, radio-frequency
Ecoil ID - STID TIM 30 - 8626694
DXTX MEDICAL INC
STID TIM 30
In Commercial Distribution

  • 00850011472194 ()


  • MRI system coil, radio-frequency
The NeoCoil 1.5T 16‐Channel Flex Coils for Siemens is a system of phased array, receive only coils forr imaging the upper and lower extremities, chest, abdomen, pelvis, head, neck, and spine in pediatric and adult populations. The NeoCoil 1.5T 16-Channel Flex Coils for Siemens is tuned to receive RF frequency corresponding to the proton precession in a 1.5 tesla magnetic field, which is governed by the Larmor equation.
NEOCOIL, LLC
44
In Commercial Distribution

  • 00856181003442 ()


  • MRI system coil, radio-frequency
The NeoCoil 1.5T 16‐Channel Flex Coils for Siemens is a system of phased array, receive only coils forr imaging the upper and lower extremities, chest, abdomen, pelvis, head, neck, and spine in pediatric and adult populations. The NeoCoil 1.5T 16-Channel Flex Coils for Siemens is tuned to receive RF frequency corresponding to the proton precession in a 1.5 tesla magnetic field, which is governed by the Larmor equation.
NEOCOIL, LLC
43
In Commercial Distribution

  • 00856181003435 ()


  • MRI system coil, radio-frequency
No Description
Aktina Corp.
57-905
In Commercial Distribution

  • B365579050 ()


  • Manual-aperture-control therapeutic x-ray system collimator, non-motorized
No Description
Aktina Corp.
56-300-MX60
In Commercial Distribution

  • B36556300MX600 ()


  • X-ray/radiation therapy beam filter, wedge
No Description
Aktina Corp.
56-300-MX45
In Commercial Distribution

  • B36556300MX450 ()


  • X-ray/radiation therapy beam filter, wedge
No Description
Aktina Corp.
56-300-MX30
In Commercial Distribution

  • B36556300MX300 ()


  • X-ray/radiation therapy beam filter, wedge
No Description
Aktina Corp.
56-300-MX15
In Commercial Distribution

  • B36556300MX150 ()


  • X-ray/radiation therapy beam filter, wedge
No Description
Aktina Corp.
56-300-MI60
In Commercial Distribution

  • B36556300MI600 ()


  • X-ray/radiation therapy beam filter, wedge
No Description
Aktina Corp.
56-300-MI45
In Commercial Distribution

  • B36556300MI450 ()


  • X-ray/radiation therapy beam filter, wedge
No Description
Aktina Corp.
56-300-MI30
In Commercial Distribution

  • B36556300MI300 ()


  • X-ray/radiation therapy beam filter, wedge
No Description
Aktina Corp.
56-300-MI15
In Commercial Distribution

  • B36556300MI150 ()


  • X-ray/radiation therapy beam filter, wedge
No Description
Aktina Corp.
56-300-DX60
In Commercial Distribution

  • B36556300DX600 ()


  • X-ray/radiation therapy beam filter, wedge
No Description
Aktina Corp.
56-300-DX45
In Commercial Distribution

  • B36556300DX450 ()


  • X-ray/radiation therapy beam filter, wedge
No Description
Aktina Corp.
56-300-DX30
In Commercial Distribution

  • B36556300DX300 ()


  • X-ray/radiation therapy beam filter, wedge
No Description
Aktina Corp.
56-300-DX15
In Commercial Distribution

  • B36556300DX150 ()


  • X-ray/radiation therapy beam filter, wedge
No Description
Aktina Corp.
56-300-DI60
In Commercial Distribution

  • B36556300DI600 ()


  • X-ray/radiation therapy beam filter, wedge
No Description
Aktina Corp.
56-300-DI45
In Commercial Distribution

  • B36556300DI450 ()


  • X-ray/radiation therapy beam filter, wedge
No Description
Aktina Corp.
56-300-DI30
In Commercial Distribution

  • B36556300DI300 ()


  • X-ray/radiation therapy beam filter, wedge
No Description
Aktina Corp.
56-300-DI15
In Commercial Distribution

  • B36556300DI150 ()


  • X-ray/radiation therapy beam filter, wedge
No Description
Aktina Corp.
53-169
In Commercial Distribution

  • B365531690 ()


  • Manual-aperture-control therapeutic x-ray system collimator, non-motorized
No Description
Aktina Corp.
52-600-SL
In Commercial Distribution

  • B36552600SL0 ()


  • Manual-aperture-control therapeutic x-ray system collimator, non-motorized
No Description
AALTO SCIENTIFIC
K818M-5
In Commercial Distribution

  • B085K818M50 ()


  • Multiple human hormone IVD, control
No Description
AALTO SCIENTIFIC
K807M-5
In Commercial Distribution

  • B085K807M50 ()


  • Multiple thyroid marker IVD, control
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