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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
1600614
Not in Commercial Distribution

  • J00716006140 ()
  • J00716006140011 ()
1600614-001

  • ENT shaver system handpiece
No Description
Bien-Air Surgery SA
1600518
Not in Commercial Distribution

  • J00716005180 ()
  • J00716005180011 ()
1600518-001

  • Bone/joint surgical power tool motor, electric
No Description
Bien-Air Surgery SA
1600076
Not in Commercial Distribution

  • J00716000760 ()
  • J00716000760011 ()
1600076-001

  • Bone/joint surgical power tool motor, electric
Irrigation Line KM (10/pkg)
OMNIA SRL
1501635-010
In Commercial Distribution

  • J00715016350011 ()
  • J00715016350101 ()


  • Disposable surgical irrigation/aspiration system
Irrigation Line (10/pkg)
OMNIA SRL
1500984-010
In Commercial Distribution

  • J00715009840101 ()
  • J00715009840011 ()


  • Disposable surgical irrigation/aspiration system
No Description
Bien-Air Surgery SA
1100491
Not in Commercial Distribution

  • J00711004910011 ()
1100491-001

  • Diamond ENT bur, single-use
No Description
Bien-Air Surgery SA
1100490
Not in Commercial Distribution

  • J00711004900011 ()
1100490-001

  • Diamond ENT bur, single-use
Chamois leather polishing brush for polishing machines, ø 90 mm
DENTAURUM GmbH & Co.KG
181-201-00
In Commercial Distribution

  • J011181201000 ()


  • Dental abrasive point, reusable
Cloth polishing brush for polishing machines, ø 100 mm
DENTAURUM GmbH & Co.KG
181-200-00
In Commercial Distribution

  • J011181200000 ()


  • Dental abrasive point, reusable
Cloth polishing brushes, mounted, for handpiece, ø 20 mm
DENTAURUM GmbH & Co.KG
181-100-01
In Commercial Distribution

  • J011181100011 ()
  • J011181100010 ()


  • Dental abrasive point, reusable
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