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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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SET STYLETTO X CHARGER ANZ
Ws Audiology Usa, Inc.
Styletto X Charger
In Commercial Distribution

  • 04063006008292 ()
10972017

  • Air-conduction hearing aid, behind-the-ear
ACC. STYLETTO X CHARGER
Ws Audiology Usa, Inc.
Styletto X Charger
In Commercial Distribution

  • 04063006004843 ()
10968447

  • Noninvasive device battery charger
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
HemCon ChitoGauzeXR PRO is a hemostatic dressing for the external, temporary control of severely bleeding wounds.
TRICOL BIOMEDICAL, INC.
1
In Commercial Distribution

  • 20870053000562 ()
  • 00870053000568 ()
  • 50870053000563 ()
1020

  • Chitosan haemostatic agent, professional, non-bioabsorbable
ChitoGauze is intended for temporary external use to stop bleeding in minor wounds.
TRICOL BIOMEDICAL, INC.
1
In Commercial Distribution

  • 50870053000303 ()
  • 00870053000308 ()
1025

  • Chitosan haemostatic agent, professional, non-bioabsorbable
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
S0100-381
In Commercial Distribution

  • 00848665039139 ()


  • Orthopaedic bone wire
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
0249
In Commercial Distribution

  • 00848665001150 ()


  • Fluted surgical drill bit, single-use, non-sterile
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