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 Inflator (SBI)
In Commercial Distribution

  • 08809300542959 ()


  • Catheter/overtube balloon inflator, single-use
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
MESH 9352515 25MM ENDCAP 15 DEGREE
MEDTRONIC SOFAMOR DANEK, INC.
9352515
Not in Commercial Distribution

  • 00613994218872 ()

  • 25mm


  • Polymeric spinal interbody fusion cage
MESH 9352504 25MM ENDCAP 4 DEGREE
MEDTRONIC SOFAMOR DANEK, INC.
9352504
Not in Commercial Distribution

  • 00613994218858 ()

  • 25mm


  • Polymeric spinal interbody fusion cage
MESH 9352500 25MM ENDCAP 0 DEGREE
MEDTRONIC SOFAMOR DANEK, INC.
9352500
In Commercial Distribution

  • 00613994218841 ()

  • 25mm


  • Polymeric spinal interbody fusion cage
MESH 9352215 22MM ENDCAP 15 DEGREE
MEDTRONIC SOFAMOR DANEK, INC.
9352215
Not in Commercial Distribution

  • 00613994218834 ()

  • 22mm


  • Polymeric spinal interbody fusion cage
MESH 9352208 22MM ENDCAP 8 DEGREE
MEDTRONIC SOFAMOR DANEK, INC.
9352208
Not in Commercial Distribution

  • 00613994218827 ()

  • 22mm


  • Polymeric spinal interbody fusion cage
MESH 9352204 22MM ENDCAP 4 DEGREE
MEDTRONIC SOFAMOR DANEK, INC.
9352204
In Commercial Distribution

  • 00613994218810 ()

  • 22mm


  • Polymeric spinal interbody fusion cage
MESH 9352200 22MM ENDCAP 0 DEGREE
MEDTRONIC SOFAMOR DANEK, INC.
9352200
In Commercial Distribution

  • 00613994218803 ()

  • 22mm


  • Polymeric spinal interbody fusion cage
MESH 9351915 19MM ENDCAP 15 DEGREE
MEDTRONIC SOFAMOR DANEK, INC.
9351915
Not in Commercial Distribution

  • 00613994218797 ()

  • 19mm


  • Polymeric spinal interbody fusion cage
MESH 9351908 19MM ENDCAP 8 DEGREE
MEDTRONIC SOFAMOR DANEK, INC.
9351908
Not in Commercial Distribution

  • 00613994218780 ()

  • 19mm


  • Polymeric spinal interbody fusion cage
MESH 9351904 19MM ENDCAP 4 DEGREE
MEDTRONIC SOFAMOR DANEK, INC.
9351904
Not in Commercial Distribution

  • 00613994218773 ()

  • 19mm


  • Polymeric spinal interbody fusion cage
No Description
OKB RITM, ZAO
SCENAR-1-NT (version 02C)
In Commercial Distribution

  • 04650057290679 ()


  • Analgesic transcutaneous electrical nerve stimulation system
No Description
OKB RITM, ZAO
SCENAR-1-NT (version 02.1C)
In Commercial Distribution

  • 04650057290662 ()


  • Analgesic transcutaneous electrical nerve stimulation system
No Description
OKB RITM, ZAO
SCENAR-1-NT (version 02.1)
In Commercial Distribution

  • 04650057290631 ()


  • Analgesic transcutaneous electrical nerve stimulation system
No Description
OKB RITM, ZAO
SCENAR-1-NT (version 02)
In Commercial Distribution

  • 04650057290082 ()


  • Analgesic transcutaneous electrical nerve stimulation system
No Description
OKB RITM, ZAO
CHANS-01-SCENAR-M
In Commercial Distribution

  • 04650057290051 ()


  • Analgesic transcutaneous electrical nerve stimulation system
Fresh scented disposable anesthesia face mask
Ambu A/S
2075
In Commercial Distribution

  • 00612649102238 ()
  • 00612649185552 ()

  • Size 2
  • 7
2075

  • Anaesthesia face mask, single-use
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