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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
1100358
Not in Commercial Distribution

  • J00711003580051 ()
  • J00711003580011 ()
1100358-001

  • Metal/carbide ENT bur, single-use
No Description
Bien-Air Surgery SA
1100357
Not in Commercial Distribution

  • J00711003570011 ()
  • J00711003570051 ()
1100357-001

  • Metal/carbide ENT bur, single-use
No Description
Bien-Air Surgery SA
1100356
Not in Commercial Distribution

  • J00711003560051 ()
  • J00711003560011 ()
1100356-001

  • Metal/carbide ENT bur, single-use
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
Sharps: 23 Qt. Btl Red
MEDEGEN MEDICAL PRODUCTS, LLC
187
In Commercial Distribution

  • H3621872 ()
  • HY3621870 ()
187

  • Sharps container
The NOVA is a Electrosurgical Pencil that has 3 LED battery powered located at the distal end for better visualization of the surgical field. The NOVA can be fitted with a smoke shroud that will remove the smoke plume from the site.The device is designed to work with all standard Electrosurgical Generators.
Pare Surgical, Inc
Hand Switching
In Commercial Distribution

  • HS101125 ()
  • HS112ESUPENCILS ()
900018

  • Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
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