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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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Sterile Disposable Kit containing single-patient-use components necessary for each platelet separation procedure with the MAGELLAN® Autologous Platelet Separator Instrument
ARTERIOCYTE MEDICAL SYSTEMS, INC.
AMS300
In Commercial Distribution

  • M896AMS3001 ()
  • M896AMS3000 ()
AMS300

  • Haematological concentrate system preparation kit, platelet concentration
Ear Loop Surgical Face Mask, Pink, Non-Sterile
Uniseal
711-2P
In Commercial Distribution

  • 30744514711243 ()
  • 20744514711246 ()
  • 10744514711249 ()


  • Surgical/medical face mask, non-antimicrobial, single-use
Maintenance products (cleaning the device and lubricate the active parts as ball bearings)are intended for use in dentistry by professional users, to maintain the proper and safe functioning of the dental instruments
Bien-Air Dental SA
1600617-001
In Commercial Distribution

  • J00716006170011 ()
  • J00716006170061 ()
1600617-001

  • Surgical instrument maintenance lubricant
Maintenance products (cleaning the device and lubricate the active parts as ball bearings)are intended for use in dentistry by professional users, to maintain the proper and safe functioning of the dental instruments
Bien-Air Dental SA
1600064-001
In Commercial Distribution

  • J00716000640011 ()
  • J00716000640061 ()
1600064-001

  • Surgical instrument maintenance lubricant
No Description
Bien-Air Surgery SA
1100364
Not in Commercial Distribution

  • J00711003640051 ()
  • J00711003640011 ()
1100364-001

  • Metal/carbide ENT bur, single-use
No Description
Bien-Air Surgery SA
1100363
Not in Commercial Distribution

  • J00711003630051 ()
  • J00711003630011 ()
1100363-001

  • Metal/carbide ENT bur, single-use
No Description
Bien-Air Surgery SA
1100362
Not in Commercial Distribution

  • J00711003620051 ()
  • J00711003620011 ()
1100362-001

  • Metal/carbide ENT bur, single-use
No Description
Bien-Air Surgery SA
1100361
Not in Commercial Distribution

  • J00711003610051 ()
  • J00711003610011 ()
1100361-001

  • Metal/carbide ENT bur, single-use
No Description
Bien-Air Surgery SA
1100360
In Commercial Distribution

  • J00711003600051 ()
  • J00711003600011 ()
1100360-001

  • Metal/carbide ENT bur, single-use
No Description
Bien-Air Surgery SA
1100359
Not in Commercial Distribution

  • J00711003590051 ()
  • J00711003590011 ()
1100359-001

  • Metal/carbide ENT bur, single-use
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