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-20)
In Commercial Distribution

  • 08809300542942 ()


  • Inflatable bone tamp
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-15)
In Commercial Distribution

  • 08809300542935 ()


  • Inflatable bone tamp
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
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
SEQUENT DISPOSABLE KIT
Conmed Corporation
SCEC047
In Commercial Distribution

  • 10845854040416 ()
SCEC047

  • Arthroscopic surgical procedure kit, non-medicated, single-use
10mm 22cm Claw Grasper, 2x3 teeth, single action, 3-piece modular scew-apart, type 10 handle: lightweight carbon-fiber with large front finger, RF post & ratchet
Avalign Technologies, Inc.
72-5210236C10M22
In Commercial Distribution

  • 00190776387495 ()


  • Rigid endoscopic tissue manipulation forceps, reusable
Alginate Alternative - Volume - 6- Pack Refill - Peppermint Scent
KERR CORPORATION
34682
In Commercial Distribution

  • 10841396118460 ()
  • 00841396118463 ()

  • Width: 2280 Millimeter


  • Silicone dental impression material
Alginate Alternative - 24-Cartridge Value Pack - Peppermint Scent
KERR CORPORATION
33817
In Commercial Distribution

  • 10841396118088 ()
  • 00841396118081 ()

  • Width: 1200 Millimeter


  • Silicone dental impression material
Alginate Alternative - Cartridge Introductory Kit - Peppermint Scent
KERR CORPORATION
33816
In Commercial Distribution

  • 10841396118071 ()
  • 00841396118074 ()

  • Width: 300 Millimeter


  • Silicone dental impression material
Alginate Alternative - Cartridge Introductory Kit - Peppermint Scent
KERR CORPORATION
33034
In Commercial Distribution

  • 10841396117869 ()
  • 00841396117862 ()

  • Width: 300 Millimeter


  • Silicone dental impression material
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