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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SILICONE MAT PERFORATED SM 225x235mm
BAHADIR USA LLC
Y852.01
In Commercial Distribution

  • 00859982006353 ()
920400

  • Instrument tray, reusable
EXTRA TRAY FEET, 4 EACH
BAHADIR USA LLC
Y835.00
In Commercial Distribution

  • 00859982006339 ()
970008

  • Instrument tray, reusable
EXTRA CRADLE FIXATION CLIPS, 4 EACH
BAHADIR USA LLC
Y854.61
In Commercial Distribution

  • 00859982006315 ()
970040

  • Instrument tray, reusable
SILICONE HOLDER 8x26x40mm, CLOSED BARBED
BAHADIR USA LLC
Y854.05
In Commercial Distribution

  • 00859982006308 ()
970030

  • Instrument tray, reusable
SILICONE HOLDER 8x26x40mm, CLOSED
BAHADIR USA LLC
Y854.03
In Commercial Distribution

  • 00859982006292 ()
970020

  • Instrument tray, reusable
SILICONE HOLDER 8x26x40mm, OPEN.
BAHADIR USA LLC
Y854.00
In Commercial Distribution

  • 00859982006285 ()
970010

  • Instrument tray, reusable
CRADLE FOR SILICONE HOLDER, 1 EACH
BAHADIR USA LLC
Y854.60P
In Commercial Distribution

  • 00859982006278 ()
970003

  • Instrument tray, reusable
CRADLE FOR SILICONE HOLDER, 4 EACH
BAHADIR USA LLC
Y854.60P
In Commercial Distribution

  • 00859982006261 ()
970002

  • Instrument tray, reusable
TRAY TAG CLIPS, METAL
BAHADIR USA LLC
Y838.00
In Commercial Distribution

  • 00859982006230 ()
971010

  • Instrument tray, reusable
U3HIT Package AD-version US
Auditdata A/S
Unity 3 HIT UNIT US package
In Commercial Distribution

  • 05711781004006 ()
21044734

  • Hearing aid tester, electrical
2000-1 Fitting Unit Audiometer
Auditdata A/S
Insert Earphone (2000-1)
In Commercial Distribution

  • 05711781002866 ()
100.056

  • Audiometric/hearing aid tester
2000-1 Fitting Unit Audiometer
Auditdata A/S
DD45 Headphone w. HBA (2000-1)
In Commercial Distribution

  • 05711781002835 ()
100.053

  • Audiometric/hearing aid tester
2000-1 Fitting Unit Audiometer
Auditdata A/S
B71 Bone Conductor (2000-1)
In Commercial Distribution

  • 05711781002804 ()
100.050

  • Audiometric/hearing aid tester
2000-1 Fitting Unit Audiometer
Auditdata A/S
Talk Back Client Microphone (2000-1)
In Commercial Distribution

  • 05711781002729 ()
100.113

  • Audiometric/hearing aid tester
No Description
Auditdata A/S
2000 Primus HIT Pro
In Commercial Distribution

  • 05711781001739 ()


  • Hearing aid tester, electrical
No Description
Auditdata A/S
OTOPro
In Commercial Distribution

  • 05711781001722 ()


  • Hearing aid tester, electrical
Siemens UNITY 3 COUPLER MICROPHONE
Ws Audiology Usa, Inc.
UNITY 3 COUPLER MICROPHONE
Not in Commercial Distribution

  • 05711781000954 ()
10823951

  • Audiometric/hearing aid tester
REAL-EAR MICROPHONE
Ws Audiology Usa, Inc.
REAL-EAR MICROPHONE
In Commercial Distribution

  • 05711781000244 ()
10823941

  • Audiometric/hearing aid tester
Siemens UNITY 3 B71 BONE CONDUCTOR
Ws Audiology Usa, Inc.
UNITY 3 B71 BONE CONDUCTOR
Not in Commercial Distribution

  • 05711781000084 ()
10823938

  • Audiometric/hearing aid tester
No Description
Auditdata A/S
2000 Primus HIT Unit
In Commercial Distribution

  • 05711781000022 ()


  • Hearing aid tester, electrical
Siemens UNITY 3 B71 BONE CONDUCTOR
Ws Audiology Usa, Inc.
UNITY 3 B71 BONE CONDUCTOR
Not in Commercial Distribution

  • 05711781000008 ()
10823938

  • Audiometric/hearing aid tester
CZ1 MNR T, 2.4G NFM SABE DEMO CORAL 1 GPL
Bernafon AG
216553
In Commercial Distribution

  • 05711584121290 ()


  • Air-conduction hearing aid, receiver-in-the-ear
CZ3 MNR T, 2.4G NFM SABE DEMO CORAL 3 GPL
Bernafon AG
216549
In Commercial Distribution

  • 05711584121283 ()


  • Air-conduction hearing aid, receiver-in-the-ear
CZ1 MNR, 2.4G NFM SABE DEMO CORAL 1 GPL
Bernafon AG
216545
In Commercial Distribution

  • 05711584121276 ()


  • Air-conduction hearing aid, receiver-in-the-ear
CZ3 MNR, 2.4G NFM SABE DEMO CORAL 3 GPL
Bernafon AG
216541
In Commercial Distribution

  • 05711584121269 ()


  • Air-conduction hearing aid, receiver-in-the-ear
CZ1 MNR T, 2.4G NFM MSIL CORAL 1 GPL
Bernafon AG
216552
In Commercial Distribution

  • 05711584121092 ()


  • Air-conduction hearing aid, receiver-in-the-ear
CZ1 MNR T, 2.4G NFM SABE/MSIL CORAL 1 GPL
Bernafon AG
216551
In Commercial Distribution

  • 05711584121085 ()


  • Air-conduction hearing aid, receiver-in-the-ear
CZ1 MNR T, 2.4G NFM MAC CORAL 1 GPL
Bernafon AG
216550
In Commercial Distribution

  • 05711584121078 ()


  • Air-conduction hearing aid, receiver-in-the-ear
CZ1 MNR, 2.4G NFM MSIL CORAL 1 GPL
Bernafon AG
216544
In Commercial Distribution

  • 05711584120811 ()


  • Air-conduction hearing aid, receiver-in-the-ear
CZ1 MNR, 2.4G NFM SABE/MSIL CORAL 1 GPL
Bernafon AG
216543
In Commercial Distribution

  • 05711584120804 ()


  • Air-conduction hearing aid, receiver-in-the-ear
CZ1 MNR, 2.4G NFM MAC CORAL 1 GPL
Bernafon AG
216542
In Commercial Distribution

  • 05711584120798 ()


  • Air-conduction hearing aid, receiver-in-the-ear
CZ3 MNR T, 2.4G NFM MSIL CORAL 3 GPL
Bernafon AG
216548
In Commercial Distribution

  • 05711584120576 ()


  • Air-conduction hearing aid, receiver-in-the-ear
CZ3 MNR T, 2.4G NFM SABE/MSIL CORAL 3 GPL
Bernafon AG
216547
In Commercial Distribution

  • 05711584120569 ()


  • Air-conduction hearing aid, receiver-in-the-ear
CZ3 MNR T, 2.4G NFM MAC CORAL 3 GPL
Bernafon AG
216546
In Commercial Distribution

  • 05711584120552 ()


  • Air-conduction hearing aid, receiver-in-the-ear
CZ3 MNR, 2.4G NFM MSIL CORAL 3 GPL
Bernafon AG
216540
In Commercial Distribution

  • 05711584120248 ()


  • Air-conduction hearing aid, receiver-in-the-ear
CZ3 MNR, 2.4G NFM SABE/MSIL CORAL 3 GPL
Bernafon AG
216539
In Commercial Distribution

  • 05711584120231 ()


  • Air-conduction hearing aid, receiver-in-the-ear
CZ3 MNR, 2.4G NFM MAC CORAL 3 GPL
Bernafon AG
216538
In Commercial Distribution

  • 05711584120224 ()


  • Air-conduction hearing aid, receiver-in-the-ear
CZ1 B 105, 2.4G NFM SABE DEMO CORAL 1 GPL
Bernafon AG
216561
In Commercial Distribution

  • 05711584120064 ()


  • Air-conduction hearing aid, behind-the-ear
CZ3 B 105, 2.4G NFM SABE DEMO CORAL 3 GPL
Bernafon AG
216557
In Commercial Distribution

  • 05711584120057 ()


  • Air-conduction hearing aid, behind-the-ear
CZ1 B 105, 2.4G NFM MSIL CORAL 1 GPL
Bernafon AG
216560
In Commercial Distribution

  • 05711584119785 ()


  • Air-conduction hearing aid, behind-the-ear
CZ1 B 105, 2.4G NFM SABE/MSIL CORAL 1 GPL
Bernafon AG
216559
In Commercial Distribution

  • 05711584119778 ()


  • Air-conduction hearing aid, behind-the-ear
CZ1 B 105, 2.4G NFM MAC CORAL 1 GPL
Bernafon AG
216558
In Commercial Distribution

  • 05711584119761 ()


  • Air-conduction hearing aid, behind-the-ear
CZ3 B 105, 2.4G NFM MSIL CORAL 3 GPL
Bernafon AG
216556
In Commercial Distribution

  • 05711584119440 ()


  • Air-conduction hearing aid, behind-the-ear
CZ3 B 105, 2.4G NFM SABE/MSIL CORAL 3 GPL
Bernafon AG
216555
In Commercial Distribution

  • 05711584119433 ()


  • Air-conduction hearing aid, behind-the-ear
CZ3 B 105, 2.4G NFM MAC CORAL 3 GPL
Bernafon AG
216554
In Commercial Distribution

  • 05711584119426 ()


  • Air-conduction hearing aid, behind-the-ear
CZ1 MNR T R, 2.4G NFM MSIL CORAL 1 GPL
Bernafon AG
216536
In Commercial Distribution

  • 05711584118887 ()


  • Air-conduction hearing aid, receiver-in-the-ear
CZ1 MNR T R, 2.4G NFM SABE/MSIL CORAL 1 GPL
Bernafon AG
216535
In Commercial Distribution

  • 05711584118870 ()


  • Air-conduction hearing aid, receiver-in-the-ear
CZ1 MNR T R, 2.4G NFM MAC CORAL 1 GPL
Bernafon AG
216534
In Commercial Distribution

  • 05711584118863 ()


  • Air-conduction hearing aid, receiver-in-the-ear
CZ3 MNR T R, 2.4G NFM MSIL CORAL 3 GPL
Bernafon AG
216532
In Commercial Distribution

  • 05711584118603 ()


  • Air-conduction hearing aid, receiver-in-the-ear
CZ3 MNR T R, 2.4G NFM SABE/MSIL CORAL 3 GPL
Bernafon AG
216531
In Commercial Distribution

  • 05711584118597 ()


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