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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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Bien Air RA Surgical Carbide #6 - STERILE
Ss White Burs, Inc.
BA81411
In Commercial Distribution

  • J007BA814110 ()
  • J007BA814111 ()
81411

  • Carbide dental bur, reusable
Bien Air RA Surgical Carbide #4 - STERILE
Ss White Burs, Inc.
BA81410
In Commercial Distribution

  • J007BA814100 ()
  • J007BA814101 ()
81410

  • Carbide dental bur, reusable
Bien Air RA Surgical Carbide #2 - STERILE
Ss White Burs, Inc.
BA81409
In Commercial Distribution

  • J007BA814090 ()
  • J007BA814091 ()
81409

  • Carbide dental bur, reusable
Bien Air RA Bone Cutter 161-016 - STERILE
Ss White Burs, Inc.
BA81408
In Commercial Distribution

  • J007BA814080 ()
  • J007BA814081 ()
81408

  • Carbide dental bur, reusable
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
No Description
Bien-Air Surgery SA
1100474
Not in Commercial Distribution

  • J00711004740011 ()
1100474-001

  • Metal/carbide ENT bur, single-use
No Description
Bien-Air Surgery SA
1100472
Not in Commercial Distribution

  • J00711004720011 ()
1100472-001

  • Metal/carbide ENT bur, single-use
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