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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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XL Drill Sleeve – 4.0 mm
Si-Bone Inc.
400035
In Commercial Distribution

  • 00863604000094 ()


  • Sacroiliac joint transarticular fixation/arthrodesis implantation kit
XL Drill Sleeve – 7.0 mm
Si-Bone Inc.
400034
In Commercial Distribution

  • 00863604000087 ()


  • Sacroiliac joint transarticular fixation/arthrodesis implantation kit
Drill Sleeve – 4.0 mm
Si-Bone Inc.
400024
In Commercial Distribution

  • 00863604000070 ()


  • Sacroiliac joint transarticular fixation/arthrodesis implantation kit
Drill Sleeve – 7.0 mm
Si-Bone Inc.
400023
In Commercial Distribution

  • 00863604000063 ()


  • Sacroiliac joint transarticular fixation/arthrodesis implantation kit
Guide Pin Extension Cap - 80mm
Si-Bone Inc.
501672
In Commercial Distribution

  • 00863604000056 ()


  • Sacroiliac joint transarticular fixation/arthrodesis implantation kit
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
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
C-01-99-0014
Not in Commercial Distribution

  • 00863593000204 ()
F-01-01-0001

  • Brachytherapy source spacer
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