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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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Neuromonitoring Kit
Si-Bone Inc.
400170
In Commercial Distribution

  • 00863604000049 ()


  • Nerve-locating system probe, single-use
No Description
Si-Bone Inc.
107590-90
In Commercial Distribution

  • 00863604000032 ()

  • Outer Diameter: 10.75 Millimeter
  • Length: 90 Millimeter


  • Sacroiliac joint transarticular fixation/arthrodesis implant, coated
No Description
Si-Bone Inc.
107585-90
In Commercial Distribution

  • 00863604000025 ()

  • Length: 85 Millimeter
  • Outer Diameter: 10.75 Millimeter


  • Sacroiliac joint transarticular fixation/arthrodesis implant, coated
No Description
Si-Bone Inc.
107580-90
In Commercial Distribution

  • 00863604000018 ()

  • Outer Diameter: 10.75 Millimeter
  • Length: 80 Millimeter


  • Sacroiliac joint transarticular fixation/arthrodesis implant, coated
No Description
Si-Bone Inc.
107575-90
In Commercial Distribution

  • 00863604000001 ()

  • Length: 75 Millimeter
  • Outer Diameter: 10.75 Millimeter


  • Sacroiliac joint transarticular fixation/arthrodesis implant, coated
No Description
OSTEOMEDIX, INC.
BDC-Cervical
In Commercial Distribution

  • 00863602000300 ()


  • Orthopaedic surgery tissue debris collector, single-use
The Fiducial Marker consists of a sealed polyether ether ketone (PEEK) polymer capsule containing a solution of up to 1.0% cobalt chloride and up to 2.0% N-Acetyl cysteine, in a ratio of 1:2. Zirconium oxide is sealed within the device. The length of the polymer capsule is between 5.5 mm and 10.0 mm, and the diameter is 1.0 mm. It is loaded in an implant needle and sterilized with Ethylene Oxide.
C4 IMAGING, LLC
F-01-03-0111
In Commercial Distribution

  • 00863593000259 ()


  • Radiological image marker, implantable
The Fiducial Marker consists of a sealed polyether ether ketone (PEEK) polymer capsule containing a solution of up to 1.0% cobalt chloride and up to 2.0% N-Acetyl cysteine, in a ratio of 1:2. Zirconium oxide is sealed within the device. The length of the polymer capsule is between 5.5 mm and 10.0 mm, and the diameter is between 0.9 mm and 1.2 mm.
C4 IMAGING, LLC
F-01-03-0011
In Commercial Distribution

  • 00863593000242 ()


  • Radiological image marker, implantable
The SIRIUS MRI Marker NS is a component device indicated as an accessory for use in conjunction with brachytherapy seed carrier sleeves and radionuclide brachytherapy sources containing one of the following isotopes: Iodine 125 (125I), Palladium 103 (103Pd) or Cesium 131 (131Cs). It is indicated for permanent interstitial implantation in the prostate of patients with confirmed prostatic malignancy.
C4 IMAGING, LLC
F-01-01-0011
In Commercial Distribution

  • 00863593000228 ()


  • Brachytherapy source spacer
The SIRIUS MRI Marker is a component device indicated as an accessory for use in conjunction with brachytherapy seed carrier sleeves and radionuclide brachytherapy sources containing one of the following isotopes: Iodine 125 (125I), Palladium 103 (103Pd) or Cesium 131 (131Cs). It is indicated for permanent interstitial implantation in the prostate of patients with confirmed prostatic malignancy.
C4 IMAGING, LLC
F-01-01-0001
In Commercial Distribution

  • 00863593000211 ()
F-01-01-0001

  • Brachytherapy source spacer
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