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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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A device designed for the parenteral administration of a drug contained in a cartridge that forms part of, is attached to, or inserted into an autoinjector (drug pen injector). It is used by persons requiring regular, self-administrated dosages of insulin, hormones, or other pharmaceuticals. This device will typically be constructed as a double-ended, stainless steel needle of various sizes that is fixed to a threaded hub of plastic to which the drug pen injector is connected. This device is packaged in a sealed sterility barrier, and might include needle shielding safety features to reduce the risk of needle stick injury. This is a single-use device.
ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO LTD
31G x 5MM
In Commercial Distribution

  • 26958697605894 ()
  • 16958697605897 ()
  • 06958697605890 ()
HWIPN3105

  • Autoinjector needle
A device designed for the parenteral administration of a drug contained in a cartridge that forms part of, is attached to, or inserted into an autoinjector (drug pen injector). It is used by persons requiring regular, self-administrated dosages of insulin, hormones, or other pharmaceuticals. This device will typically be constructed as a double-ended, stainless steel needle of various sizes that is fixed to a threaded hub of plastic to which the drug pen injector is connected. This device is packaged in a sealed sterility barrier, and might include needle shielding safety features to reduce the risk of needle stick injury. This is a single-use device.
ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO LTD
31G x 4MM
In Commercial Distribution

  • 26958697605887 ()
  • 16958697605880 ()
  • 06958697605883 ()
HWIPN3104

  • Autoinjector needle
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.
4.0 x 12mm
In Commercial Distribution

  • 00195451000119 ()

  • Balloon Proximal Outer Diameter (OD): 0.047 Inch
  • Balloon Diameter: 4.0 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
C2IVL4012

  • Intravascular lithotripsy system balloon catheter, coronary
The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology
ACCESS SCIENTIFIC, LLC
3Fr x 5cm
In Commercial Distribution

  • 20859821006692 ()
  • 10859821006695 ()
  • 00859821006698 ()

  • Needle Gauge: 21 Gauge
  • Catheter Gauge: 3 French
  • Catheter Length: 5 Centimeter
96001

  • Peripheral vascular catheter
No Description
CRAWFORD HEALTHCARE LIMITED
16 x 16in
In Commercial Distribution

  • 05060077233706 ()
  • 05060077233690 ()
  • 05060077233683 ()

  • Length: 16 Inch
  • Height: 16 Inch
CWL1163

  • Exudate-absorbent dressing, hydrophilic-gel, antimicrobial
PowerHeal 3-layer clear adhesive, 6" x 6" "
Vomaris Wound Care, Inc.
6" x 6"
In Commercial Distribution

  • 00810198031546 ()

  • Length: 6 Inch
  • Width: 6 Inch
PFK-6060

  • Bioelectric wound dressing
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
1110-405
In Commercial Distribution

  • 00848665029673 ()


  • Tibia nail, non-sterile
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
1111-405
In Commercial Distribution

  • 00848665029604 ()


  • Tibia nail, non-sterile
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
8085-090
In Commercial Distribution

  • 00848665027037 ()


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
8085-085
In Commercial Distribution

  • 00848665027020 ()


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
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