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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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KIT M-CORE R-LI 80 ANZ1 SB
Ws Audiology Usa, Inc.
KIT M-Core R-Li 80
In Commercial Distribution

  • 04056839122617 ()
10980481

  • Air-conduction hearing aid, receiver-in-canal
KIT M-CORE R-LI 80 ANZ1 DBR
Ws Audiology Usa, Inc.
KIT M-Core R-Li 80
In Commercial Distribution

  • 04056839122594 ()
10980483

  • Air-conduction hearing aid, receiver-in-canal
KIT M-CORE R-LI 80 ANZ1 BLK
Ws Audiology Usa, Inc.
KIT M-Core R-Li 80
In Commercial Distribution

  • 04056839122587 ()
10980484

  • Air-conduction hearing aid, receiver-in-canal
KIT M-CORE R-LI 80 JPN GNT
Ws Audiology Usa, Inc.
KIT M-Core R-Li 80
In Commercial Distribution

  • 04056839122563 ()
10980486

  • Air-conduction hearing aid, receiver-in-canal
KIT M-CORE R-LI 80 JPN RGD
Ws Audiology Usa, Inc.
KIT M-Core R-Li 80
In Commercial Distribution

  • 04056839122549 ()
10980488

  • Air-conduction hearing aid, receiver-in-canal
KIT M-CORE R-LI 80 JPN DKC
Ws Audiology Usa, Inc.
KIT M-Core R-Li 80
In Commercial Distribution

  • 04056839122532 ()
10980489

  • Air-conduction hearing aid, receiver-in-canal
KIT M-CORE R-LI 80 JPN PRL
Ws Audiology Usa, Inc.
KIT M-Core R-Li 80
In Commercial Distribution

  • 04056839122525 ()
10980490

  • Air-conduction hearing aid, receiver-in-canal
KIT M-CORE R-LI 80 UK1 BLK
Ws Audiology Usa, Inc.
KIT M-Core R-Li 80
In Commercial Distribution

  • 04056839122259 ()
10980517

  • Air-conduction hearing aid, receiver-in-canal
KIT M-CORE R-LI 80 UK1 SLV
Ws Audiology Usa, Inc.
KIT M-Core R-Li 80
In Commercial Distribution

  • 04056839122235 ()
10980519

  • Air-conduction hearing aid, receiver-in-canal
KIT M-CORE R-LI 80 UK1 PRL
Ws Audiology Usa, Inc.
KIT M-Core R-Li 80
In Commercial Distribution

  • 04056839122211 ()
10980521

  • Air-conduction hearing aid, receiver-in-canal
KIT M-CORE R-LI 80 UK1 RGD
Ws Audiology Usa, Inc.
KIT M-Core R-Li 80
In Commercial Distribution

  • 04056839122198 ()
10980523

  • Air-conduction hearing aid, receiver-in-canal
KIT M-CORE R-LI 80 UK1 GNT
Ws Audiology Usa, Inc.
KIT M-Core R-Li 80
In Commercial Distribution

  • 04056839122174 ()
10980525

  • Air-conduction hearing aid, receiver-in-canal
Miracle-Ear HA MECONNECT R 312T 3 XP GR Hearing Aid
Ws Audiology Usa, Inc.
HA MECONNECT R 312T 3 XP GR
In Commercial Distribution

  • 04056839110843 ()
10970301

  • Air-conduction hearing aid, in-the-ear
Miracle-Ear HA MECONNECT R 312T 4 XP GR Hearing Aid
Ws Audiology Usa, Inc.
HA MECONNECT R 312T 4 XP GR
In Commercial Distribution

  • 04056839110836 ()
10970302

  • Air-conduction hearing aid, in-the-ear
Miracle-Ear HA MECONNECT R 312T 5 XP GR Hearing Aid
Ws Audiology Usa, Inc.
HA MECONNECT R 312T 5 XP GR
In Commercial Distribution

  • 04056839110829 ()
10970303

  • Air-conduction hearing aid, in-the-ear
Miracle-Ear HA MECONNECT R 312T 5 XP PRL Hearing Aid
Ws Audiology Usa, Inc.
HA MECONNECT R 312T 5 XP PRL
In Commercial Distribution

  • 04056839110812 ()
10970304

  • Air-conduction hearing aid, in-the-ear
Miracle-Ear HA MECONNECT R 312T 4 XP PRL Hearing Aid
Ws Audiology Usa, Inc.
HA MECONNECT R 312T 4 XP PRL
In Commercial Distribution

  • 04056839110805 ()
10970305

  • Air-conduction hearing aid, in-the-ear
Miracle-Ear HA MECONNECT R 312T 3 XP PRL Hearing Aid
Ws Audiology Usa, Inc.
HA MECONNECT R 312T 3 XP PRL
In Commercial Distribution

  • 04056839110799 ()
10970306

  • Air-conduction hearing aid, in-the-ear
Miracle-Ear HA MECONNECT R 312T 3 XP RGD Hearing Aid
Ws Audiology Usa, Inc.
HA MECONNECT R 312T 3 XP RGD
In Commercial Distribution

  • 04056839110782 ()
10970307

  • Air-conduction hearing aid, in-the-ear
Miracle-Ear HA MECONNECT R 312T 4 XP RGD Hearing Aid
Ws Audiology Usa, Inc.
HA MECONNECT R 312T 4 XP RGD
In Commercial Distribution

  • 04056839110775 ()
10970308

  • Air-conduction hearing aid, in-the-ear
Miracle-Ear HA MECONNECT R 312T 5 XP RGD Hearing Aid
Ws Audiology Usa, Inc.
HA MECONNECT R 312T 5 XP RGD
In Commercial Distribution

  • 04056839110768 ()
10970309

  • Air-conduction hearing aid, in-the-ear
Miracle-Ear HA MECONNECT R 312T 5 XP SLH Hearing Aid
Ws Audiology Usa, Inc.
HA MECONNECT R 312T 5 XP SLH
In Commercial Distribution

  • 04056839110751 ()
10970310

  • Air-conduction hearing aid, in-the-ear
Miracle-Ear HA MECONNECT R 312T 4 XP SLH Hearing Aid
Ws Audiology Usa, Inc.
HA MECONNECT R 312T 4 XP SLH
In Commercial Distribution

  • 04056839110744 ()
10970311

  • Air-conduction hearing aid, in-the-ear
Miracle-Ear HA MECONNECT R 312T 3 XP SLH Hearing Aid
Ws Audiology Usa, Inc.
HA MECONNECT R 312T 3 XP SLH
In Commercial Distribution

  • 04056839110737 ()
10970312

  • Air-conduction hearing aid, in-the-ear
Rexton HA M-CORE R312 80 BG Hearing Aid
Ws Audiology Usa, Inc.
HA M-CORE R312 80 BG
In Commercial Distribution

  • 04056839110645 ()
10968754

  • Air-conduction hearing aid, behind-the-ear
Rexton HA M-CORE R312 80 BLK Hearing Aid
Ws Audiology Usa, Inc.
HA M-CORE R312 80 BLK
In Commercial Distribution

  • 04056839110638 ()
10968755

  • Air-conduction hearing aid, behind-the-ear
Rexton HA M-CORE R312 80 DBR Hearing Aid
Ws Audiology Usa, Inc.
HA M-CORE R312 80 DBR
In Commercial Distribution

  • 04056839110621 ()
10968756

  • Air-conduction hearing aid, behind-the-ear
Rexton HA M-CORE R312 80 DKC Hearing Aid
Ws Audiology Usa, Inc.
HA M-CORE R312 80 DKC
In Commercial Distribution

  • 04056839110614 ()
10968757

  • Air-conduction hearing aid, behind-the-ear
Rexton HA M-CORE R312 80 GR Hearing Aid
Ws Audiology Usa, Inc.
HA M-CORE R312 80 GR
In Commercial Distribution

  • 04056839110607 ()
10968758

  • Air-conduction hearing aid, behind-the-ear
Rexton HA M-CORE R312 80 GNT Hearing Aid
Ws Audiology Usa, Inc.
HA M-CORE R312 80 GNT
In Commercial Distribution

  • 04056839110591 ()
10968759

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