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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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Balloon Catheter - 00842429106945

Scepter XC
MICROVENTION INC.
BC0411XC-ID-2
In Commercial Distribution

  • 00842429106945 ()

  • 4.0 mm x 11 mm
BC0411XC

  • Intravascular occluding balloon catheter, image-guided

Balloon Catheter - 00842429106907

Scepter C
MICROVENTION INC.
BC0420C-ID-2
In Commercial Distribution

  • 00842429106907 ()

  • 4.0 mm x 20 mm
BC0420C

  • Intravascular occluding balloon catheter, image-guided

Balloon Catheter - 00842429106891

Scepter C
MICROVENTION INC.
BC0415C-ID-2
In Commercial Distribution

  • 00842429106891 ()

  • 4.0 mm x 15 mm
BC0415C

  • Intravascular occluding balloon catheter, image-guided

Balloon Catheter - 00842429106884

Scepter C
MICROVENTION INC.
BC0410C-ID-2
In Commercial Distribution

  • 00842429106884 ()

  • 4.0 mm x 10 mm
BC0410C

  • Intravascular occluding balloon catheter, image-guided

Balloon Catheter - 00842429106563

Scepter Mini
MICROVENTION INC.
BC0210M-US
In Commercial Distribution

  • 00842429106563 ()

  • 2.2 mm x 9 mm
BC0210M

  • Intravascular occluding balloon catheter, image-guided

Balloon Catheter - 00842429103418

Scepter XC
MICROVENTION INC.
BC0411XC-ID-700
In Commercial Distribution

  • 00842429103418 ()

  • 4.0 mm x 11 mm
BC0411XC

  • Intravascular occluding balloon catheter, image-guided

Balloon Catheter - 00842429103401

Scepter C
MICROVENTION INC.
BC0420C-ID-700
In Commercial Distribution

  • 00842429103401 ()

  • 4.0 mm x 20 mm
BC0420C

  • Intravascular occluding balloon catheter, image-guided

Balloon Catheter - 00842429103395

Scepter C
MICROVENTION INC.
BC0415C-ID-700
In Commercial Distribution

  • 00842429103395 ()

  • 4.0 mm x 15 mm
BC0415C

  • Intravascular occluding balloon catheter, image-guided

Balloon Catheter - 00842429103388

Scepter C
MICROVENTION INC.
BC0410C-ID-700
In Commercial Distribution

  • 00842429103388 ()

  • 4.0 mm x 10 mm
BC0410C

  • Intravascular occluding balloon catheter, image-guided

SpineKure Kyphoplasty System - 08809300542973

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
SpineKure Kyphoplasty System
In Commercial Distribution

  • 08809300542973 ()


  • Balloon kyphoplasty kit

SpineKure Kyphoplasty System - 08809300542966

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
Cement Delivery System (SCDS)
In Commercial Distribution

  • 08809300542966 ()


  • Stomal appliance cement

SpineKure Kyphoplasty System - 08809300542959

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

SpineKure Kyphoplasty System - 08809300542942

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

SpineKure Kyphoplasty System - 08809300542935

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

SpineKure Kyphoplasty System - 08809300542928

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

Maritime First Aid Resupply - Advanced - M6898141003010

The Maritime First Aid Family of Kits provide users with Advanced Medical products for use in medical trauma scenarios.
Safeguard US Operating, LLC
01
In Commercial Distribution

  • M6898141003010 ()
81-410-03

  • First aid kit, non-medicated, single-use

oximeter - RO2 - 00382098017062

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 - 10845854040416

SEQUENT DISPOSABLE KIT
Conmed Corporation
SCEC047
In Commercial Distribution

  • 10845854040416 ()
SCEC047

  • Arthroscopic surgical procedure kit, non-medicated, single-use

Millennium - 00190776387495

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

KLOCKNER - 08435451601261

EC LONG TRANSFER SCERW
SOADCO, S.L.
10 09 04.2 L
In Commercial Distribution

  • 08435451601261 ()
10 09 04.2 L

  • Dental implant suprastructure kit
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