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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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No Description
Bien-Air Surgery SA
1100355
Not in Commercial Distribution

  • J00711003550051 ()
  • J00711003550011 ()
1100355-001

  • Metal/carbide ENT bur, single-use
No Description
Bien-Air Surgery SA
1100354
Not in Commercial Distribution

  • J00711003540051 ()
  • J00711003540011 ()
1100354-001

  • Metal/carbide ENT bur, single-use
No Description
Bien-Air Surgery SA
1100353
Not in Commercial Distribution

  • J00711003530051 ()
  • J00711003530011 ()
1100353-001

  • Metal/carbide ENT bur, single-use
No Description
Bien-Air Surgery SA
1100352
Not in Commercial Distribution

  • J00711003520051 ()
  • J00711003520011 ()
1100352-005

  • Metal/carbide ENT bur, single-use
No Description
Bien-Air Surgery SA
1100351
Not in Commercial Distribution

  • J00711003510051 ()
  • J00711003510011 ()
1100351-001

  • Metal/carbide ENT bur, single-use
Syntrax Support Catheter, .018" x 180cm
ANGIODYNAMICS, INC.
18-180
In Commercial Distribution

  • H787181801 ()
  • H787181800 ()
  • 15051684029568 ()

  • Catheter Gauge: 4 French
  • Length: 180 Centimeter
  • Max Guidewire OD - 0.018"


  • Vascular guide-catheter, single-use
Percutaneous Introducer Sheath
ANGIODYNAMICS, INC.
18100204
In Commercial Distribution

  • H787181002045 ()
  • H787181002040 ()
  • 15051684018944 ()

  • Catheter Gauge: 7 French


  • Vascular catheter introduction set, nonimplantable
Percutaneous Introducer Sheath
ANGIODYNAMICS, INC.
18100203
In Commercial Distribution

  • H787181002035 ()
  • H787181002030 ()
  • 15051684018937 ()

  • Catheter Gauge: 6 French


  • Vascular catheter introduction set, nonimplantable
Percutaneous Introducer Set
ANGIODYNAMICS, INC.
18100201
In Commercial Distribution

  • H787181002015 ()
  • H787181002010 ()
  • 15051684018920 ()

  • Needle Gauge: 18 Gauge
  • Catheter Gauge: 6 French


  • Vascular catheter introduction set, nonimplantable
Venacure EVLT NeverTouch Direct Introducer Sheath
ANGIODYNAMICS, INC.
16510001
In Commercial Distribution

  • H787165100010 ()
  • H787165100011 ()
  • 15051684014724 ()

  • Length: 10 Centimeter
  • Catheter Gauge: 4 French


  • Varicose vein lasing procedure kit
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