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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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TruHearing HA TH PREMIUM POWER BTE 19 SB Hearing Aid
Ws Audiology Usa, Inc.
HA TH PREMIUM POWER BTE 19 SB
In Commercial Distribution

  • 04056839089118 ()
10961888

  • Air-conduction hearing aid, behind-the-ear
TruHearing HA TH ADVANCED POWER BTE19 BG Hearing Aid
Ws Audiology Usa, Inc.
HA TH ADVANCED POWER BTE19 BG
In Commercial Distribution

  • 04056839089101 ()
10961889

  • Air-conduction hearing aid, behind-the-ear
TruHearing HA TH ADVANCED POWER BTE19 DBR Hearing Aid
Ws Audiology Usa, Inc.
HA TH ADVANCED POWER BTE19 DBR
In Commercial Distribution

  • 04056839089095 ()
10961890

  • Air-conduction hearing aid, behind-the-ear
TruHearing HA TH ADVANCED POWER BTE19 GNT Hearing Aid
Ws Audiology Usa, Inc.
HA TH ADVANCED POWER BTE19 GNT
In Commercial Distribution

  • 04056839089088 ()
10961891

  • Air-conduction hearing aid, behind-the-ear
TruHearing HA TH ADVANCED POWER BTE19 BLK Hearing Aid
Ws Audiology Usa, Inc.
HA TH ADVANCED POWER BTE19 BLK
In Commercial Distribution

  • 04056839089071 ()
10961892

  • Air-conduction hearing aid, behind-the-ear
TruHearing HA TH ADVANCED POWER BTE19 SB Hearing Aid
Ws Audiology Usa, Inc.
HA TH ADVANCED POWER BTE19 SB
In Commercial Distribution

  • 04056839089064 ()
10961893

  • Air-conduction hearing aid, behind-the-ear
Audio Service S_ITE TUNE QUIX G5 R MOC TRD Hearing Aid
Ws Audiology Usa, Inc.
S_ITE TUNE QUIX G5 R MOC TRD
Not in Commercial Distribution

  • 04056839088395 ()
10960060

  • Air-conduction hearing aid, in-the-ear
Audio Service S_ITE TUNE QUIX G5 L MOC TBLU Hearing Aid
Ws Audiology Usa, Inc.
S_ITE TUNE QUIX G5 L MOC TBLU
Not in Commercial Distribution

  • 04056839088388 ()
10960059

  • Air-conduction hearing aid, in-the-ear
Audio Service S_ITE TUNE QUIX G5 R BLK TRD Hearing Aid
Ws Audiology Usa, Inc.
S_ITE TUNE QUIX G5 R BLK TRD
Not in Commercial Distribution

  • 04056839088371 ()
10960058

  • Air-conduction hearing aid, in-the-ear
Audio Service S_ITE TUNE QUIX G5 L BLK TBLU Hearing Aid
Ws Audiology Usa, Inc.
S_ITE TUNE QUIX G5 L BLK TBLU
Not in Commercial Distribution

  • 04056839088364 ()
10960057

  • Air-conduction hearing aid, in-the-ear
Audio Service S_ITE CROS QUIX G5 R MOC TRD Hearing Aid
Ws Audiology Usa, Inc.
S_ITE CROS QUIX G5 R MOC TRD
Not in Commercial Distribution

  • 04056839088357 ()
10960052

  • Air-conduction hearing aid, in-the-ear
Audio Service S_ITE CROS QUIX G5 L MOC TBLU Hearing Aid
Ws Audiology Usa, Inc.
S_ITE CROS QUIX G5 L MOC TBLU
Not in Commercial Distribution

  • 04056839088340 ()
10960051

  • Air-conduction hearing aid, in-the-ear
Audio Service S_ITE CROS QUIX G5 R BLK TRD Hearing Aid
Ws Audiology Usa, Inc.
S_ITE CROS QUIX G5 R BLK TRD
Not in Commercial Distribution

  • 04056839088333 ()
10960050

  • Air-conduction hearing aid, in-the-ear
Audio Service S_ITE CROS QUIX G5 L BLK TBLU Hearing Aid
Ws Audiology Usa, Inc.
S_ITE CROS QUIX G5 L BLK TBLU
Not in Commercial Distribution

  • 04056839088326 ()
10960049

  • Air-conduction hearing aid, in-the-ear
Rexton S_ITE CROS INOX 8C R MOC TRD
Ws Audiology Usa, Inc.
S_ITE CROS INOX 8C R MOC TRD
In Commercial Distribution

  • 04056839088319 ()
10960048

  • Air-conduction hearing aid, in-the-ear
Rexton S_ITE CROS INOX 8C L MOC TBLU
Ws Audiology Usa, Inc.
S_ITE CROS INOX 8C L MOC TBLU
In Commercial Distribution

  • 04056839088302 ()
10960047

  • Air-conduction hearing aid, in-the-ear
Rexton S_ITE CROS INOX 8C R BLK TRD
Ws Audiology Usa, Inc.
S_ITE CROS INOX 8C R BLK TRD
In Commercial Distribution

  • 04056839088296 ()
10960046

  • Air-conduction hearing aid, in-the-ear
Rexton S_ITE CROS INOX 8C L BLK TBLU
Ws Audiology Usa, Inc.
S_ITE CROS INOX 8C L BLK TBLU
In Commercial Distribution

  • 04056839088289 ()
10960045

  • Air-conduction hearing aid, in-the-ear
Audio Service S_ITE TUNE T 2.0 QUIX G5 R BLK TRD Hearing Aid
Ws Audiology Usa, Inc.
S_ITE TUNE T 2.0 QUIX G5 R BLK TRD
Not in Commercial Distribution

  • 04056839088272 ()
10960043

  • Air-conduction hearing aid, in-the-ear
Audio Service S_ITE TUNE T 2.0 QUIX G5 L BLK TBLU Hearing Aid
Ws Audiology Usa, Inc.
S_ITE TUNE T 2.0 QUIX G5 L BLK TBLU
Not in Commercial Distribution

  • 04056839088265 ()
10960042

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