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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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WIN 202, ITE KIT L PI
Bernafon AG
116-21-111-10
In Commercial Distribution

  • 05711584019542 ()


  • Air-conduction hearing aid, in-the-ear
WIN 202, ITE KIT L BE
Bernafon AG
116-21-110-10
In Commercial Distribution

  • 05711584019535 ()


  • Air-conduction hearing aid, in-the-ear
WIN 202, ITE KIT R PI
Bernafon AG
116-21-101-10
In Commercial Distribution

  • 05711584019528 ()


  • Air-conduction hearing aid, in-the-ear
WIN 202, ITE KIT R BE
Bernafon AG
116-21-100-10
In Commercial Distribution

  • 05711584019511 ()


  • Air-conduction hearing aid, in-the-ear
NEO 401 CIC, KIT FP BE
Bernafon AG
116-20-810-10
In Commercial Distribution

  • 05711584019412 ()


  • Air-conduction hearing aid, canal
NEO 315 ITC DM, KIT L PI
Bernafon AG
116-20-611-10
In Commercial Distribution

  • 05711584019313 ()


  • Air-conduction hearing aid, canal
NEO 315 ITC DM, KIT L BE
Bernafon AG
116-20-610-10
In Commercial Distribution

  • 05711584019306 ()


  • Air-conduction hearing aid, canal
NEO 315 ITC DM, KIT R PI
Bernafon AG
116-20-601-10
In Commercial Distribution

  • 05711584019290 ()


  • Air-conduction hearing aid, canal
NEO 315 ITC DM, KIT R BE
Bernafon AG
116-20-600-10
In Commercial Distribution

  • 05711584019283 ()


  • Air-conduction hearing aid, canal
CT5 N, PS SF DB CANTEO 5
Bernafon AG
111840
In Commercial Distribution

  • 05711584005798 ()


  • Air-conduction hearing aid, behind-the-ear
CT7 N, PS SF GB CANTEO 7
Bernafon AG
111834
In Commercial Distribution

  • 05711584005781 ()


  • Air-conduction hearing aid, behind-the-ear
CT9 N, PS SF GB CANTEO 9
Bernafon AG
111830
In Commercial Distribution

  • 05711584005767 ()


  • Air-conduction hearing aid, behind-the-ear
CT9 N, PS SF DB CANTEO 9
Bernafon AG
111829
In Commercial Distribution

  • 05711584005750 ()


  • Air-conduction hearing aid, behind-the-ear
CT5 M, VC PS SF GB CANTEO 5
Bernafon AG
111813
In Commercial Distribution

  • 05711584005644 ()


  • Air-conduction hearing aid, behind-the-ear
CT7 M, VC PS SF MAC CANTEO 7
Bernafon AG
111810
In Commercial Distribution

  • 05711584005620 ()


  • Air-conduction hearing aid, behind-the-ear
CT7 M, VC PS SF GB CANTEO 7
Bernafon AG
111809
In Commercial Distribution

  • 05711584005613 ()


  • Air-conduction hearing aid, behind-the-ear
Convenience tray for the Macy Catheter. Contents include: Macy Catheter, 60ml Enteral/Oral Syringe, 10ml Enteral/Oral Syringe, 3ml Enteral/Oral Syringe, (2) 10ml Pre-filled Balloon Inflation Syringes, Macy Catheter Instructions for Use, 3-Ply Poly Towel, Nitrile Gloves, Lubricating Jelly, Catheter Securing Device.
HOSPI CORPORATION
B
In Commercial Distribution

  • 00861003000226 ()
  • 10861003000223 ()
MCT-1001

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated
Convenience kit for the Macy Catheter. Contents include: Macy Catheter, Liqui-Pill Assembly, Water Reservoir Assembly, 20ml Luer Lock Syringe, 3ml Exteral/Oral Syringe, 10ml Enteral/Oral Syringe, Macy Catheter Instructions for Use, Macy Catheter Bedside Care Kit Manual, Macy Catheter Medication Sheet (2), 3-Ply Poly Towel, Lubricating Jelly, Nitrile Gloves, Catheter Securing Device.
HOSPI CORPORATION
D
In Commercial Distribution

  • 00861003000219 ()
  • 10861003000216 ()
MCK-1001

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated
The Macy Catheter is intended to provide rectal access to administer liquids/medications.
HOSPI CORPORATION
E
In Commercial Distribution

  • 00861003000202 ()
MAC-1001

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated
Ova1® is a qualitative serum test that combines the results of five immunoassays into a single numerical result. It is indicated for women who meet the following criteria: over age 18, ovarian adnexal mass present for which surgery is planned, and not yet referred to an oncologist. Ova1® is an aid to further assess the likelihood that malignancy is present when the physician’s independent clinical and radiological evaluation does not indicate malignancy. The test is not intended as a screening or stand-alone diagnostic assay.
Aspira Women's Health Inc.
3.0.3.006
In Commercial Distribution

  • 00860942000113 ()


  • Medical equipment clinical data interfacing software
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