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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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SET CROS PURE CHARGE&GO BG
Ws Audiology Usa, Inc.
CROS PURE CHARGE&GO NX
In Commercial Distribution

  • 04063006000258 ()
10964552

  • Air-conduction hearing aid, behind-the-ear
HA STYLETTO 1X B BLK BLKG
Ws Audiology Usa, Inc.
Styletto 1X
In Commercial Distribution

  • 04063006015085 ()
10995811

  • Air-conduction hearing aid, receiver-in-canal
HA STYLETTO 1X B SNW SNWG
Ws Audiology Usa, Inc.
Styletto 1X
In Commercial Distribution

  • 04063006015078 ()
10995813

  • Air-conduction hearing aid, receiver-in-canal
HA STYLETTO 2X B BLK BLKG
Ws Audiology Usa, Inc.
Styletto 2X
In Commercial Distribution

  • 04063006015061 ()
10995814

  • Air-conduction hearing aid, receiver-in-canal
HA STYLETTO 2X B SNW SNWG
Ws Audiology Usa, Inc.
Styletto 2X
In Commercial Distribution

  • 04063006015054 ()
10995815

  • Air-conduction hearing aid, receiver-in-canal
Active Pro Demo Kit Black-Silver
Ws Audiology Usa, Inc.
Active Pro Demo Kit
In Commercial Distribution

  • 04063006014804 ()
10991470

  • Air-conduction hearing aid, receiver-in-canal
C_ITE INSIO 2NX CIC
Ws Audiology Usa, Inc.
Insio 2Nx CIC
In Commercial Distribution

  • 04063006013425 ()
10986215

  • Air-conduction hearing aid, in-the-ear
C_ITE INSIO 1NX CIC
Ws Audiology Usa, Inc.
Insio 1Nx CIC
In Commercial Distribution

  • 04063006013418 ()
10986216

  • Air-conduction hearing aid, in-the-ear
C_ITE INSIO 2NX IIC
Ws Audiology Usa, Inc.
Insio 2Nx IIC
In Commercial Distribution

  • 04063006013401 ()
10986217

  • Air-conduction hearing aid, in-the-ear
C_ITE INSIO 1NX IIC
Ws Audiology Usa, Inc.
Insio 1Nx IIC
In Commercial Distribution

  • 04063006013395 ()
10986218

  • Air-conduction hearing aid, in-the-ear
Pure 312 2X Pearl White
Ws Audiology Usa, Inc.
Styletto 3X Kit
In Commercial Distribution

  • 04063006013067 ()
10981737

  • Air-conduction hearing aid, receiver-in-canal
Pure 312 2X Rose Gold
Ws Audiology Usa, Inc.
Pure 312 2X
In Commercial Distribution

  • 04063006013050 ()
10981739

  • Air-conduction hearing aid, receiver-in-canal
HA PURE 312 2X SB
Ws Audiology Usa, Inc.
Pure 312 2X
In Commercial Distribution

  • 04063006013043 ()
10981741

  • Air-conduction hearing aid, receiver-in-canal
Pure 312 2X Silver(926)
Ws Audiology Usa, Inc.
Pure 312 2X
In Commercial Distribution

  • 04063006013036 ()
10981743

  • Air-conduction hearing aid, receiver-in-canal
Pure 312 2X [T] Beige
Ws Audiology Usa, Inc.
Pure 312 2X
In Commercial Distribution

  • 04063006013029 ()
10981810

  • Air-conduction hearing aid, receiver-in-canal
Pure 312 2X [T] Black
Ws Audiology Usa, Inc.
Pure 312 2X
In Commercial Distribution

  • 04063006013012 ()
10981812

  • Air-conduction hearing aid, receiver-in-canal
Pure 312 2X [T] Dark Brown
Ws Audiology Usa, Inc.
Pure 312 2X
In Commercial Distribution

  • 04063006013005 ()
10981814

  • Air-conduction hearing aid, receiver-in-canal
Pure 312 2X [T] Dark Champagne
Ws Audiology Usa, Inc.
Pure 312 2X
In Commercial Distribution

  • 04063006012992 ()
10981816

  • Air-conduction hearing aid, receiver-in-canal
Silk 5X L Black
Ws Audiology Usa, Inc.
Silk 5X
In Commercial Distribution

  • 04063006010509 ()
10967893

  • Air-conduction hearing aid, receiver-in-canal
SET CHG INDUCTIVE II(JPN)
Ws Audiology Usa, Inc.
Inductive Charger II
In Commercial Distribution

  • 04063006010288 ()
10976047

  • Air-conduction hearing aid, behind-the-ear
CROS Pure Charge&Go X Sandy Brown
Ws Audiology Usa, Inc.
CROS Pure Charge&Go X
In Commercial Distribution

  • 04063006010202 ()
10968172

  • Contralateral hearing unit
CROS Pure Charge&Go X Dark Brown
Ws Audiology Usa, Inc.
CROS Pure Charge&Go X
In Commercial Distribution

  • 04063006010196 ()
10968169

  • Contralateral hearing unit
CROS Pure Charge&Go X Beige
Ws Audiology Usa, Inc.
CROS Pure Charge&Go X
In Commercial Distribution

  • 04063006010189 ()
10968168

  • Contralateral hearing unit
CROS Pure Charge&Go X Black
Ws Audiology Usa, Inc.
CROS Pure Charge&Go X
In Commercial Distribution

  • 04063006010172 ()
10968171

  • Contralateral hearing unit
CROS Pure Charge&Go X Grey
Ws Audiology Usa, Inc.
CROS Pure Charge&Go X
In Commercial Distribution

  • 04063006010165 ()
10968867

  • Contralateral hearing unit
CROS Pure Charge&Go X Granite
Ws Audiology Usa, Inc.
CROS Pure Charge&Go X
In Commercial Distribution

  • 04063006010158 ()
10968176

  • Contralateral hearing unit
CROS Pure Charge&Go X Rose Gold
Ws Audiology Usa, Inc.
CROS Pure Charge&Go X
In Commercial Distribution

  • 04063006010141 ()
10968175

  • Contralateral hearing unit
CROS Pure Charge&Go X Dark Champagne
Ws Audiology Usa, Inc.
CROS Pure Charge&Go X
In Commercial Distribution

  • 04063006010134 ()
10968174

  • Contralateral hearing unit
CROS Pure Charge&Go X Pearl White
Ws Audiology Usa, Inc.
CROS Pure Charge&Go X
In Commercial Distribution

  • 04063006010127 ()
10968173

  • Contralateral hearing unit
CROS Pure Charge&Go X Silver Hero
Ws Audiology Usa, Inc.
CROS Pure Charge&Go X
In Commercial Distribution

  • 04063006010110 ()
10968170

  • Contralateral hearing unit
KIT STYLETTO 7X CN BLK BLKG
Ws Audiology Usa, Inc.
Kit Styletto 7X
In Commercial Distribution

  • 04063006010073 ()
10970043

  • Air-conduction hearing aid, behind-the-ear
KIT STYLETTO 7X EU BLK BLKG
Ws Audiology Usa, Inc.
Kit Styletto 7X
In Commercial Distribution

  • 04063006010066 ()
10970066

  • Air-conduction hearing aid, behind-the-ear
Styletto 7X Kit Black Black Gloss
Ws Audiology Usa, Inc.
Styletto 7X Kit
In Commercial Distribution

  • 04063006010059 ()
10970067

  • Air-conduction hearing aid, receiver-in-canal
KIT STYLETTO 7X UK BLK BLKG
Ws Audiology Usa, Inc.
Kit Styletto 7X
In Commercial Distribution

  • 04063006010042 ()
10970068

  • Air-conduction hearing aid, behind-the-ear
KIT STYLETTO 7X ANZ BLK BLKG
Ws Audiology Usa, Inc.
Kit Styletto 7X
In Commercial Distribution

  • 04063006010035 ()
10970069

  • Air-conduction hearing aid, behind-the-ear
KIT STYLETTO 7X CN SNW SNWG
Ws Audiology Usa, Inc.
Kit Styletto 7X
In Commercial Distribution

  • 04063006010028 ()
10970070

  • Air-conduction hearing aid, behind-the-ear
KIT STYLETTO 7X CN SNW RGD
Ws Audiology Usa, Inc.
Kit Styletto 7X
In Commercial Distribution

  • 04063006010011 ()
10970071

  • Air-conduction hearing aid, behind-the-ear
KIT STYLETTO 7X CN COS RGD
Ws Audiology Usa, Inc.
Kit Styletto 7X
In Commercial Distribution

  • 04063006010004 ()
10970072

  • Air-conduction hearing aid, behind-the-ear
KIT STYLETTO 7X CN BLK SLV
Ws Audiology Usa, Inc.
Kit Styletto 7X
In Commercial Distribution

  • 04063006009992 ()
10970073

  • Air-conduction hearing aid, behind-the-ear
KIT STYLETTO 7X EU SNW SNWG
Ws Audiology Usa, Inc.
Kit Styletto 7X
In Commercial Distribution

  • 04063006009985 ()
10970074

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