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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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Rexton - 05714880193749

HA BICORE B M 10 PRL
Ws Audiology Usa, Inc.
BiCore B M 10
In Commercial Distribution

  • 05714880193749 ()
21024280

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

Rexton - 05714880193725

HA BICORE B M 10 SB
Ws Audiology Usa, Inc.
BiCore B M 10
In Commercial Distribution

  • 05714880193725 ()
21024283

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

Rexton - 05714880191035

Rexton HA BICORE B HP 20 GR Hearing Aid
Ws Audiology Usa, Inc.
BiCore B HP 20
In Commercial Distribution

  • 05714880191035 ()
21024509

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

Rexton - 05714880191011

Rexton HA BICORE B HP 20 SLV Hearing Aid
Ws Audiology Usa, Inc.
BiCore B HP 20
In Commercial Distribution

  • 05714880191011 ()
21024505

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

Rexton - 05714880190991

Rexton HA BICORE B HP 20 GNT Hearing Aid
Ws Audiology Usa, Inc.
BiCore B HP 20
In Commercial Distribution

  • 05714880190991 ()
21024501

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

Rexton - 05714880190892

Rexton HA BICORE B HP 30 SLV Hearing Aid
Ws Audiology Usa, Inc.
BiCore B HP 30
In Commercial Distribution

  • 05714880190892 ()
21024487

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

hear.com - 05714880190571

Horizon 5AX RIC-R Dark Champaigne(37)
Ws Audiology Usa, Inc.
Horizon 5AX RIC-R
In Commercial Distribution

  • 05714880190571 ()
21024381

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

Rexton - 05714880190229

HA BICORE B P 30 BLK
Ws Audiology Usa, Inc.
BiCore B P 30
In Commercial Distribution

  • 05714880190229 ()
21023919

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

Rexton - 05714880190205

HA BICORE B P 30 DKC
Ws Audiology Usa, Inc.
BiCore B P 30
In Commercial Distribution

  • 05714880190205 ()
21023921

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

Rexton - 05714880190182

HA BICORE B P 30 GR
Ws Audiology Usa, Inc.
BiCore B P 30
In Commercial Distribution

  • 05714880190182 ()
21023923

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

Rexton - 05714880190175

HA BICORE B P 30 PRL
Ws Audiology Usa, Inc.
BiCore B P 30
In Commercial Distribution

  • 05714880190175 ()
21023924

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

Rexton - 05714880190168

HA BICORE B P 30 RGD
Ws Audiology Usa, Inc.
BiCore B P 30
In Commercial Distribution

  • 05714880190168 ()
21023925

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

Rexton - 05714880190151

HA BICORE B P 30 SB
Ws Audiology Usa, Inc.
BiCore B P 30
In Commercial Distribution

  • 05714880190151 ()
21023926

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

Rexton - 05714880190137

HA BICORE B P 20 BLK
Ws Audiology Usa, Inc.
BiCore B P 20
In Commercial Distribution

  • 05714880190137 ()
21023928

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

Rexton - 05714880190113

HA BICORE B P 20 DBR
Ws Audiology Usa, Inc.
BiCore B P 20
In Commercial Distribution

  • 05714880190113 ()
21023930

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

Rexton - 05714880190090

HA BICORE B P 20 GNT
Ws Audiology Usa, Inc.
BiCore B P 20
In Commercial Distribution

  • 05714880190090 ()
21023932

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

Rexton - 05714880190083

HA BICORE B P 20 GR
Ws Audiology Usa, Inc.
BiCore B P 20
In Commercial Distribution

  • 05714880190083 ()
21023933

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

Rexton - 05714880190076

HA BICORE B P 20 PRL
Ws Audiology Usa, Inc.
BiCore B P 20
In Commercial Distribution

  • 05714880190076 ()
21023934

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

Rexton - 05714880190052

HA BICORE B P 20 SB
Ws Audiology Usa, Inc.
BiCore B P 20
In Commercial Distribution

  • 05714880190052 ()
21023936

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

Rexton - 05714880190038

BiCore B P sDemo Granite
Ws Audiology Usa, Inc.
BiCore B P sDemo
In Commercial Distribution

  • 05714880190038 ()
21023938

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

Rexton - 05714880190014

HA BICORE B P 10 DBR
Ws Audiology Usa, Inc.
BiCore B P 10
In Commercial Distribution

  • 05714880190014 ()
21023940

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

Rexton - 05714880189995

HA BICORE B P 10 GNT
Ws Audiology Usa, Inc.
BiCore B P 10
In Commercial Distribution

  • 05714880189995 ()
21023942

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

Rexton - 05714880189971

HA BICORE B P 10 PRL
Ws Audiology Usa, Inc.
BiCore B P 10
In Commercial Distribution

  • 05714880189971 ()
21023944

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

Rexton - 05714880189964

HA BICORE B P 10 RGD
Ws Audiology Usa, Inc.
BiCore B P 10
In Commercial Distribution

  • 05714880189964 ()
21023945

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

Rexton - 05714880189957

HA BICORE B P 10 SB
Ws Audiology Usa, Inc.
BiCore B P 10
In Commercial Distribution

  • 05714880189957 ()
21023946

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

Rexton - 05714880189940

HA BICORE B P 10 SLV
Ws Audiology Usa, Inc.
BiCore B P 10
In Commercial Distribution

  • 05714880189940 ()
21023947

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

Amplifon - 05714880189445

ampli-energy B 2MC R Silver
Ws Audiology Usa, Inc.
ampli-energy B 2MC R
In Commercial Distribution

  • 05714880189445 ()
21023750

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

Amplifon - 05714880189421

ampli-energy B 2MC R Black
Ws Audiology Usa, Inc.
ampli-energy B 2MC R
In Commercial Distribution

  • 05714880189421 ()
21023748

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

CONNEXX - 05714880187595

SET CHG STATION B-M WO PLUG
Ws Audiology Usa, Inc.
Charging Station B-M
In Commercial Distribution

  • 05714880187595 ()
21023329

  • Noninvasive device battery charger

CONNEXX - 05714880187229

APP CONNEXX FIT2GO
Ws Audiology Usa, Inc.
Connexx Fit2Go
In Commercial Distribution

  • 05714880187229 ()
21023158

  • Audiometric/hearing device software

CONNEXX - 05714880184969

SET CHARGING STATION B-M JP
Ws Audiology Usa, Inc.
Charging Station B-M
In Commercial Distribution

  • 05714880184969 ()
21022898

  • Noninvasive device battery charger

CONNEXX - 05714880184051

SET CHARGING STATION B-M IN
Ws Audiology Usa, Inc.
Charging Station B-M
In Commercial Distribution

  • 05714880184051 ()
21022712

  • Noninvasive device battery charger

CONNEXX - 05714880184020

SET CHARGING STATION B-M ANZ
Ws Audiology Usa, Inc.
Charging Station B-M
In Commercial Distribution

  • 05714880184020 ()
21022709

  • Noninvasive device battery charger

SIGNIA - 05714880183726

C_ITE INSIO 7IX IIC
Ws Audiology Usa, Inc.
Insio 7IX IIC
In Commercial Distribution

  • 05714880183726 ()
21000770

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

SIGNIA - 05714880183702

C_ITE INSIO 3IX IIC
Ws Audiology Usa, Inc.
Insio 3IX IIC
In Commercial Distribution

  • 05714880183702 ()
21000772

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

SIGNIA - 05714880183689

C_ITE INSIO 3IX CIC
Ws Audiology Usa, Inc.
Insio 3IX CIC
In Commercial Distribution

  • 05714880183689 ()
21022573

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

SIGNIA - 05714880183672

C_ITE INSIO 5IX CIC
Ws Audiology Usa, Inc.
Insio 5IX CIC
In Commercial Distribution

  • 05714880183672 ()
21022572

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

SIGNIA - 05714880183665

C_ITE INSIO 7IX CIC
Ws Audiology Usa, Inc.
Insio 7IX CIC
In Commercial Distribution

  • 05714880183665 ()
21022571

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

SIGNIA - 05714880183658

C_ITE INSIO 1IX IIC
Ws Audiology Usa, Inc.
Insio 1IX IIC
In Commercial Distribution

  • 05714880183658 ()
21008137

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

SIGNIA - 05714880183641

C_ITE INSIO 1IX CIC
Ws Audiology Usa, Inc.
Insio 1IX CIC
In Commercial Distribution

  • 05714880183641 ()
21022575

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

Rexton - 05714880183344

BiCore Custom Li ITE 30
Ws Audiology Usa, Inc.
BiCore Custom Li ITE 30
In Commercial Distribution

  • 05714880183344 ()
21022438

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

Rexton - 05714880183313

C_ITE BICORE CUSTOM LI ITC 30
Ws Audiology Usa, Inc.
BiCore Custom Li ITC 30
In Commercial Distribution

  • 05714880183313 ()
21022436

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

SIGNIA - 05714880183184

HA INTUIS SP 4.1 SB
Ws Audiology Usa, Inc.
Intuis SP 4.1
In Commercial Distribution

  • 05714880183184 ()
21015066

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

SIGNIA - 05714880183177

HA INTUIS SP 4.1 RGD
Ws Audiology Usa, Inc.
Intuis SP 4.1
In Commercial Distribution

  • 05714880183177 ()
21015063

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

SIGNIA - 05714880183160

HA INTUIS SP 4.1 PRL
Ws Audiology Usa, Inc.
Intuis SP 4.1
In Commercial Distribution

  • 05714880183160 ()
21015054

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

SIGNIA - 05714880183153

HA INTUIS SP 4.1 GPH
Ws Audiology Usa, Inc.
Intuis SP 4.1
In Commercial Distribution

  • 05714880183153 ()
21015052

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

SIGNIA - 05714880183139

HA INTUIS SP 4.1 DKC
Ws Audiology Usa, Inc.
Intuis SP 4.1
In Commercial Distribution

  • 05714880183139 ()
21015047

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

SIGNIA - 05714880183115

HA INTUIS SP 4.1 BLK
Ws Audiology Usa, Inc.
Intuis SP 4.1
In Commercial Distribution

  • 05714880183115 ()
21015042

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

SIGNIA - 05714880182996

HA INTUIS SP 4.0 SLH
Ws Audiology Usa, Inc.
Intuis SP 4.0
In Commercial Distribution

  • 05714880182996 ()
21015091

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

SIGNIA - 05714880182972

HA INTUIS SP 4.0 RGD
Ws Audiology Usa, Inc.
Intuis SP 4.0
In Commercial Distribution

  • 05714880182972 ()
21015087

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