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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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CROS Pure C&G IX DEEP BROWN
Ws Audiology Usa, Inc.
CROS Pure C&G IX
In Commercial Distribution

  • 05714880204490 ()
21026189

  • Contralateral hearing unit
CROS Pure C&G IX DARK CHAMPAGNE
Ws Audiology Usa, Inc.
CROS Pure C&G IX
In Commercial Distribution

  • 05714880204483 ()
21026190

  • Contralateral hearing unit
CROS Pure C&G IX FINE GOLD
Ws Audiology Usa, Inc.
CROS Pure C&G IX
In Commercial Distribution

  • 05714880204476 ()
21026191

  • Contralateral hearing unit
CROS Pure C&G IX PEARL WHITE
Ws Audiology Usa, Inc.
CROS Pure C&G IX
In Commercial Distribution

  • 05714880204452 ()
21026193

  • Contralateral hearing unit
CROS Pure C&G IX ROSE GOLD
Ws Audiology Usa, Inc.
CROS Pure C&G IX
In Commercial Distribution

  • 05714880204445 ()
21026194

  • Contralateral hearing unit
CROS Pure C&G IX SANDY BROWN
Ws Audiology Usa, Inc.
CROS Pure C&G IX
In Commercial Distribution

  • 05714880204438 ()
21026195

  • Contralateral hearing unit
HA MOTION C&G SP 3X SB
Ws Audiology Usa, Inc.
Motion C&G SP 3X
In Commercial Distribution

  • 05714880104509 ()
10980264

  • Air-conduction hearing aid, behind-the-ear
BakTablCovr44"x90" 960/G;2.25milN-S,zone lam
A PLUS INTERNATIONAL INC.
1
In Commercial Distribution

  • 80683534080456 ()
  • 00683534080450 ()
BT44090-1F

  • Medical equipment/instrument drape, single-use
Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio
Fujirebio Diagnostics, Inc.
CL0073
In Commercial Distribution

  • 00869164000086 ()


  • Tau protein IVD, kit, chemiluminescent immunoassay
  • Amyloid B component IVD, kit, chemiluminescent immunoassay
HA PURE C&G T 2AX SLH
Ws Audiology Usa, Inc.
PURE C&G T 2AX
In Commercial Distribution

  • 05714880127744 ()
10997152

  • Air-conduction hearing aid, receiver-in-canal
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