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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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single use RF head coil for MRI imaging during neuro MRI-guided FUS treatment. a part of 1.5T neuro kit for USA (SET000937)
INSIGHTEC LTD
Neuro Head coil
In Commercial Distribution

  • 07290015461184 ()
ASC002258-AA

  • Therapeutic oncological/gynaecological ultrasound system
Selenia® Dimensions® digital mammography system generates digital mammographic images that can be used for screening and diagnosis of breast cancer.
Hologic, Inc.
3D software
In Commercial Distribution

  • 15420045500013 ()
SW-01648

  • Stationary mammographic x-ray system, digital
Single Patient Use Filshie® Clip Application Kit for Minilaparotomy. Includes one Sterishot Minilap Applicator and one pair of Filshie® Clips.
FEMCARE LIMITED
AVM-951M
In Commercial Distribution

  • 15055515602197 ()
  • 45055515602358 ()
  • 15055515602357 ()
AVM-951M

  • Fallopian tube clip/band
Single Patient Use Filshie® Clip Application Kit for Minilaparotomy. Includes one Sterishot Minilap Applicator and one pair of Filshie® Clips.
FEMCARE LIMITED
AVM-951M
Not in Commercial Distribution

  • 25055515602194 ()
  • 15055515602197 ()
AVM-951M

  • Fallopian tube clip/band
Selenia® Dimensions® Mobile digital mammography system is a mobile mammographic system used for capturing digital x-ray images of the breast.
Hologic, Inc.
3DM-SYS-INTL2D-MOB
In Commercial Distribution

  • 15420045510593 ()
3DM-SYS-INTL2D-MOB

  • Stationary mammographic x-ray system, digital
Selenia® Dimensions® Mobile digital mammography system is a mobile mammographic system used for capturing digital x-ray images of the breast.
Hologic, Inc.
3DM-SYS-INTL3D-MOB
In Commercial Distribution

  • 15420045510562 ()
3DM-SYS-INTL3D-MOB

  • Stationary mammographic x-ray system, digital
Selenia® Dimensions® digital mammography system generates digital mammographic images that can be used for screening and diagnosis of breast cancer.
Hologic, Inc.
ASY-10636-3D
In Commercial Distribution

  • 15420045508033 ()
ASY-10636-3D

  • Stationary mammographic x-ray system, digital
Selenia® Dimensions® digital mammography system generates digital mammographic images that can be used for screening and diagnosis of breast cancer.
Hologic, Inc.
3DIMENSIONS SOFTWARE
In Commercial Distribution

  • 15420045507296 ()
SW-04883

  • Stationary mammographic x-ray system, digital
The Shockwave C2 Catheter is a proprietary lithotripsy device delivered through the coronary arterial system of the heart to the site of an otherwise difficult to treat calcified stenosis, including calcified stenosis that are anticipated to exhibit resistance to full balloon dilation or subsequent uniform coronary stent expansion. The IVL Catheter contains integrated lithotripsy emitters for the localized delivery of acoustic pressure pulse therapy. The lithotripsy technology generates acoustic pressure pulses within the target treatment site, disrupting calcium within the lesion allowing subsequent dilatation of a coronary artery stenosis using low balloon pressure. The system consists of the IVL Catheter, IVL Connector Cable and IVL Generator. The Shockwave C2 Catheter is available in four (4) sizes: 2.5x12mm, 3.0x12mm, 3.5x12mm, and 4.0x12mm. The Shockwave C2 is compatible with a 6F guiding catheter and extensions, has a working length of 138cm, and shaft depth markers at the proximal end. The catheter is coated with hydrophilic coating to 22.75 cm from the distal tip to reduce friction during device delivery.
Shockwave Medical, Inc.
3.5 x 12mm
In Commercial Distribution

  • 00195451000102 ()

  • Balloon Proximal Outer Diameter (OD): 0.045 Inch
  • Balloon Diameter: 3.5 Millimeter
  • Balloon Length: 12 Millimeter
  • Catheter Working Length: 138 Centimeter
  • Introducer Sheath Compatibility: 6 French
  • Guidewire Diameter: 0.014 Inch
  • Balloon Nominal (Inflation) Pressure: 6 Atmosphere
  • Balloon Rated Burst Pressure: 10 Atmosphere
C2IVL3512

  • Intravascular lithotripsy system balloon catheter, coronary
The Shockwave C2 Catheter is a proprietary lithotripsy device delivered through the coronary arterial system of the heart to the site of an otherwise difficult to treat calcified stenosis, including calcified stenosis that are anticipated to exhibit resistance to full balloon dilation or subsequent uniform coronary stent expansion. The IVL Catheter contains integrated lithotripsy emitters for the localized delivery of acoustic pressure pulse therapy. The lithotripsy technology generates acoustic pressure pulses within the target treatment site, disrupting calcium within the lesion allowing subsequent dilatation of a coronary artery stenosis using low balloon pressure. The system consists of the IVL Catheter, IVL Connector Cable and IVL Generator. The Shockwave C2 Catheter is available in four (4) sizes: 2.5x12mm, 3.0x12mm, 3.5x12mm, and 4.0x12mm. The Shockwave C2 is compatible with a 6F guiding catheter and extensions, has a working length of 138cm, and shaft depth markers at the proximal end. The catheter is coated with hydrophilic coating to 22.75 cm from the distal tip to reduce friction during device delivery.
Shockwave Medical, Inc.
3.0 x 12mm
In Commercial Distribution

  • 00195451000096 ()

  • Balloon Diameter: 3.0 Millimeter
  • Balloon Length: 12 Millimeter
  • Catheter Working Length: 138 Centimeter
  • Introducer Sheath Compatibility: 6 French
  • Balloon Proximal Outer Diameter (OD): 0.045 Inch
  • Guidewire Diameter: 0.014 Inch
  • Balloon Nominal (Inflation) Pressure: 6 Atmosphere
  • Balloon Rated Burst Pressure: 10 Atmosphere
C2IVL3012

  • Intravascular lithotripsy system balloon catheter, coronary
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