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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The SpineKure Kyphoplasty System is designed to reduce spinal compression fracture and restore sagittal alignment by creating a space in the vertebral body to facilitate the insertion of bone cement. The SpineKure Kyphoplasty System is comprised of a Balloon Catheter, Balloon Inflator and Cement Delivery System (Accessories kit). The Balloon Catheter’s main components are the shaft, hub and the inflatable balloon located at the distal tip. The surface of balloon is covered with a silicone lubricant to enhance the insertion and withdrawal of catheter. Radiopaque markers located at the distal and proximal end of deflated working surface allow fluoroscopic visualization of the deflated balloon catheter during positioning. The Balloon Inflator (SBI) is a disposable device with an integral pressure gauge. The Cement Delivery System (SCDS) are consist of Bone Access Needle (SBN), Cement Filler & Pusher (SFP), Cannula & Expander (SCE), Drill Bit (SDB), Wire-pin (SWP-T, SWP-R).
HAN CHANG CO., LTD
Balloon Catheter (SBC-10)
In Commercial Distribution

  • 08809300542928 ()


  • Inflatable bone tamp
Balloon Catheter
MICROVENTION INC.
BC0411XC-B-ID
In Commercial Distribution

  • 00842636020607 ()

  • 4.0 mm x 11 mm
BC0411XC

  • Intravascular occluding balloon catheter, image-guided
Balloon Catheter
MICROVENTION INC.
BC0420C-B-ID
In Commercial Distribution

  • 00842636020584 ()

  • 4.0 mm x 20 mm
BC0420C

  • Intravascular occluding balloon catheter, image-guided
Balloon Catheter
MICROVENTION INC.
BC0410C-B-ID
In Commercial Distribution

  • 00842636020560 ()

  • 4.0 mm x 10 mm
BC0410C

  • Intravascular occluding balloon catheter, image-guided
Balloon Catheter
MICROVENTION INC.
BC0415C-ID
In Commercial Distribution

  • 00842636020546 ()

  • 4.0 mm x 15 mm
BC0415C

  • Intravascular occluding balloon catheter, image-guided
Scanbody retention screw
MEDENTiKA GmbH
R 60 SB
In Commercial Distribution

  • EMKAR60SB9 ()
  • 04251574826404 ()

  • Scew vent implant System of Zimmer
R 60 SB

  • Dental implant abutment analog, intraoral-scanning, single-use
The pulse oximeter is a reusable device and intended for spot-checking of oxygen saturation and pulse rate for use with the finger of adult patients in healthcare environments. And it is not intended to be used under motion or low perfusion scenarios.
Raya Pharmaceuticals LLC
1
In Commercial Distribution

  • 00382098017062 ()


  • Pulse oximeter probe, reusable
Balloon Catheter
MICROVENTION INC.
BC0411XC-ID
In Commercial Distribution

  • 00842636020591 ()

  • 4.0 mm x 11 mm
BC0411XC

  • Intravascular occluding balloon catheter, image-guided
Balloon Catheter
MICROVENTION INC.
BC0415C-B-ID
In Commercial Distribution

  • 00842636020577 ()

  • 4.0 mm x 15 mm
BC0415C

  • Intravascular occluding balloon catheter, image-guided
Balloon Catheter
MICROVENTION INC.
BC0420C-ID
In Commercial Distribution

  • 00842636020553 ()

  • 4.0 mm x 20 mm
BC0420C

  • Intravascular occluding balloon catheter, image-guided
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