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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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PR305, ITC KIT R BE PRIO
Bernafon AG
116-22-300-10
In Commercial Distribution

  • 05711584019863 ()


  • Air-conduction hearing aid, canal
PR205, ITE KIT R BE PRIO
Bernafon AG
116-22-200-10
In Commercial Distribution

  • 05711584019825 ()


  • Air-conduction hearing aid, in-the-ear
WIN 322, NO VC KIT L BE
Bernafon AG
116-21-630-10
In Commercial Distribution

  • 05711584019740 ()


  • Air-conduction hearing aid, in-the-ear
WIN 322, NO VC KIT R BE
Bernafon AG
116-21-620-10
In Commercial Distribution

  • 05711584019733 ()


  • Air-conduction hearing aid, in-the-ear
WIN 322, ITC KIT L PI
Bernafon AG
116-21-611-10
In Commercial Distribution

  • 05711584019726 ()


  • Air-conduction hearing aid, canal
WIN 322, ITC KIT L BE
Bernafon AG
116-21-610-10
In Commercial Distribution

  • 05711584019719 ()


  • Air-conduction hearing aid, canal
WIN 315, ITC DM KIT R PI
Bernafon AG
116-21-501-10
In Commercial Distribution

  • 05711584019665 ()


  • Air-conduction hearing aid, canal
The ProGen PC design concept is predicated on providing an easy to use device for platelet rich plasma (PRP) that demonstrates high platelet yield in a highly reproducible manner. This is accomplished by inclusion of design elements that provide appropriate directional, and selectable, cell layer aspiration within the horizontally dispersed “buffy coat” in the centrifuge tube design. The design resembles the shape, and general construction, of a standard 50ml centrifuge tube, but differs from such standard products by inclusion of proprietary structural components. The similarities in design allow such devices to be centrifuged in any tabletop centrifuge that accepts a 50ml tube and is, additionally, capable of 1900 RCF at 3500 RPM, 4X50ml capacity and 30-minute timer.
CELLMEDIX HOLDINGS, LLC
BELL-82380-A
In Commercial Distribution

  • 00861122000312 ()
  • 10861122000319 ()
BELL-82380-A

  • Haematological concentrate system preparation kit, platelet concentration
The Centrepid PC design concept is predicated on providing an easy to use device for platelet rich plasma (PRP) that demonstrates high platelet yield in a highly reproducible manner. This is accomplished by inclusion of design elements that provide appropriate directional, and selectable, cell layer aspiration within the horizontally dispersed “buffy coat” in the centrifuge tube design. The design resembles the shape, and general construction, of a standard 50ml centrifuge tube, but differs from such standard products by inclusion of proprietary structural components. The similarities in design allow such devices to be centrifuged in any tabletop centrifuge that accepts a 50ml tube and is, additionally, capable of 1900 RCF at 3500 RPM, 4X50ml capacity and 30-minute timer.
CELLMEDIX HOLDINGS, LLC
CELL-80180-A
In Commercial Distribution

  • 10861122000302 ()
  • 00861122000305 ()
CELL-80180-A

  • Haematological concentrate system preparation kit, platelet concentration
NEO 322 ITC, KIT L PI
Bernafon AG
116-20-511-10
In Commercial Distribution

  • 05711584019276 ()


  • Air-conduction hearing aid, canal
NEO 322 ITC, KIT L BE
Bernafon AG
116-20-510-10
In Commercial Distribution

  • 05711584019269 ()


  • Air-conduction hearing aid, canal
NEO 322 ITC, KIT R PI
Bernafon AG
116-20-501-10
In Commercial Distribution

  • 05711584019252 ()


  • Air-conduction hearing aid, canal
NEO 322 ITC, KIT R BE
Bernafon AG
116-20-500-10
In Commercial Distribution

  • 05711584019245 ()


  • Air-conduction hearing aid, canal
NEO 302 ITC, KIT L PI
Bernafon AG
116-20-411-10
In Commercial Distribution

  • 05711584019238 ()


  • Air-conduction hearing aid, canal
NEO 302 ITC, KIT L BE
Bernafon AG
116-20-410-10
In Commercial Distribution

  • 05711584019221 ()


  • Air-conduction hearing aid, canal
NEO 302 ITC, KIT R PI
Bernafon AG
116-20-401-10
In Commercial Distribution

  • 05711584019214 ()


  • Air-conduction hearing aid, canal
NEO 302 ITC, KIT R BE
Bernafon AG
116-20-400-10
In Commercial Distribution

  • 05711584019207 ()


  • Air-conduction hearing aid, canal
NEO 301 ITC, KIT L PI
Bernafon AG
116-20-311-10
In Commercial Distribution

  • 05711584019191 ()


  • Air-conduction hearing aid, canal
NEO 301 ITC, KIT L BE
Bernafon AG
116-20-310-10
In Commercial Distribution

  • 05711584019184 ()


  • Air-conduction hearing aid, canal
NEO 301 ITC, KIT R PI
Bernafon AG
116-20-301-10
In Commercial Distribution

  • 05711584019177 ()


  • Air-conduction hearing aid, canal
NEO 301 ITC, KIT R BE
Bernafon AG
116-20-300-10
In Commercial Distribution

  • 05711584019160 ()


  • Air-conduction hearing aid, canal
NEO 202 ITE, KIT L PI
Bernafon AG
116-20-111-10
In Commercial Distribution

  • 05711584019078 ()


  • Air-conduction hearing aid, in-the-ear
NEO 202 ITE, KIT L BE
Bernafon AG
116-20-110-10
In Commercial Distribution

  • 05711584019061 ()


  • Air-conduction hearing aid, in-the-ear
NEO 202 ITE, KIT R PI
Bernafon AG
116-20-101-10
In Commercial Distribution

  • 05711584019054 ()


  • Air-conduction hearing aid, in-the-ear
NEO 202 ITE, KIT R BE
Bernafon AG
116-20-100-10
In Commercial Distribution

  • 05711584019047 ()


  • Air-conduction hearing aid, in-the-ear
XP 120, BTE VC PS BE
Bernafon AG
112-10-900-00
In Commercial Distribution

  • 05711584009208 ()


  • Air-conduction hearing aid, behind-the-ear
CT5 N, PS SF MAC CANTEO 5
Bernafon AG
111899
In Commercial Distribution

  • 05711584005989 ()


  • Air-conduction hearing aid, behind-the-ear
CT7 N, PS SF MAC CANTEO 7
Bernafon AG
111898
In Commercial Distribution

  • 05711584005972 ()


  • Air-conduction hearing aid, behind-the-ear
CT9 N, PS SF MAC CANTEO 9
Bernafon AG
111897
In Commercial Distribution

  • 05711584005965 ()


  • Air-conduction hearing aid, behind-the-ear
CT5 N, PS SF GB CANTEO 5
Bernafon AG
111841
In Commercial Distribution

  • 05711584005804 ()


  • Air-conduction hearing aid, behind-the-ear
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