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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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EVERFLO w/O2 Percentage Indicator, 120V US, BRAZIL
Respironics, Inc.
EVERFLO w/O2 Percentage Indicator, 120V US, BR
In Commercial Distribution

  • 00606959032750 ()
1020002BR

  • Stationary oxygen concentrator
PillCam™ WS, v9 USA
Given Imaging, Inc.
FGS-0674
In Commercial Distribution

  • 07290110361167 ()


  • Video capsule endoscopy system application software
No Description
OSADA ELECTRIC CO.,LTD.
EXL-M40
In Commercial Distribution

  • 04580406860478 ()
3223

  • Dental laboratory power tool system
  • Line-powered dental drilling system
  • Dental power tool system, line-powered
No Description
OSADA ELECTRIC CO.,LTD.
XL-230
In Commercial Distribution

  • 04580406860461 ()
3192

  • Dental power tool system, line-powered
  • Dental laboratory power tool system
  • Line-powered dental drilling system
No Description
Sarstedt Aktiengesellschaft & Co.KG
77578010
In Commercial Distribution

  • 04038917189965 ()
  • 04038917113861 ()
77.578.010

  • 24-hour urine specimen container IVD, no additive
No Description
Dynarex Corporation
3202UB-1
In Commercial Distribution

  • 00840117332492 ()
  • 00840117334618 ()
  • 00840117332485 ()


  • Absorbent wound compression pad
No Description
Bird & Cronin, LLC
08143392
In Commercial Distribution

  • 00610570189496 ()


  • Hot/cold therapy pack, single-use
ISQ Measurement Peg
Osstell AB
Osstell SmartPeg Type 24
In Commercial Distribution

  • 09010522000229 ()
  • 09010522001363 ()
100412

  • Dental implant stability resonance frequency analysis peg
No Description
edelweiss dentistry products gmbh
13214
In Commercial Distribution

  • 09120046321547 ()


  • Dental composite resin
  • Dental veneer, professional
No Description
edelweiss dentistry products gmbh
13213
In Commercial Distribution

  • 09120046321530 ()


  • Dental veneer, professional
  • Dental composite resin
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