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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Enamelast Syringe 2pk - Cool Mint
ULTRADENT PRODUCTS, INC.
4349
Not in Commercial Distribution

  • 00883205102850 ()
4349

  • Dental coating, tooth-desensitizing
Enamelast Unit Dose 5pk - Cool Mint
ULTRADENT PRODUCTS, INC.
4354
In Commercial Distribution

  • 00883205102843 ()
4354

  • Dental coating, tooth-desensitizing
Enamelast Syringe 20pk - Orange Cream
ULTRADENT PRODUCTS, INC.
4347
Not in Commercial Distribution

  • 00883205102812 ()
4347

  • Dental coating, tooth-desensitizing
Enamelast Syringe 2pk - Orange Cream
ULTRADENT PRODUCTS, INC.
4346
Not in Commercial Distribution

  • 00883205102805 ()
4346

  • Dental coating, tooth-desensitizing
Enamelast Unit Dose 5pk - Orange Cream
ULTRADENT PRODUCTS, INC.
4345
In Commercial Distribution

  • 00883205102799 ()
4345

  • Dental coating, tooth-desensitizing
UltraEZ Tray Delivery, Upper/Lower Combo Kit
ULTRADENT PRODUCTS, INC.
5721
In Commercial Distribution

  • 00883205102690 ()
5721

  • Dental coating, tooth-desensitizing
UltraEz Mini Kit
ULTRADENT PRODUCTS, INC.
5743
In Commercial Distribution

  • 00883205102652 ()
5743

  • Dental coating, tooth-desensitizing
Enamelast Unit Dose 5pk - Walterberry
ULTRADENT PRODUCTS, INC.
4526
In Commercial Distribution

  • 00883205101754 ()
4526

  • Dental coating, tooth-desensitizing
Enamelast 200pk Application Brushes
ULTRADENT PRODUCTS, INC.
4529
In Commercial Distribution

  • 00883205021533 ()
4529

  • Dental coating, tooth-desensitizing
FluoriMax 2.5% NaF Varnish Salted CARAMEL Flavor Labeled Bottle
ELEVATE ORAL CARE, LLC
530MT1018
In Commercial Distribution

  • 00858290006215 ()
  • 00858290006253 ()
  • 00858290006246 ()
  • 00858290006260 ()

  • Total Volume: 12 Milliliter
530CM1018

  • Dental coating, tooth-desensitizing
STERILE OTC BASIC PACK
Cardinal Health 200, LLC
SBA5CBPGSB
In Commercial Distribution

  • 50887488789840 ()
  • 10887488789842 ()
SBA5CBPGSB

  • General surgical procedure kit, non-medicated, single-use
1T,FDA, OTC,1ng
Hangzhou AllTest Biotech Co., Ltd.
DFY-A102H A2553
In Commercial Distribution

  • 06936983149310 ()
USFTY1AT-1

  • Fentanyl IVD, kit, rapid ICT, clinical
OTC Combo TENS+EMS
GEMORE TECHNOLOGY CO., LTD.
GM540TE
In Commercial Distribution

  • 24712832961625 ()
  • 04712832961621 ()
GM540TE

  • Analgesic transcutaneous electrical nerve stimulation system
OTC Combo TENS+EMS
GEMORE TECHNOLOGY CO., LTD.
GM530TE
In Commercial Distribution

  • 24712832961595 ()
  • 04712832961591 ()
GM530TE

  • Analgesic transcutaneous electrical nerve stimulation system
OTC Combo TENS+EMS
GEMORE TECHNOLOGY CO., LTD.
GM520TE
In Commercial Distribution

  • 24712832961564 ()
  • 04712832961560 ()
GM520TE

  • Analgesic transcutaneous electrical nerve stimulation system
OTC Combo TENS+EMS
GEMORE TECHNOLOGY CO., LTD.
GM511TE
In Commercial Distribution

  • 24712832961533 ()
  • 04712832961539 ()
GM511TE

  • Analgesic transcutaneous electrical nerve stimulation system
OTC Combo TENS+EMS
GEMORE TECHNOLOGY CO., LTD.
GM510TE
In Commercial Distribution

  • 24712832961502 ()
  • 04712832961508 ()
GM510TE

  • Analgesic transcutaneous electrical nerve stimulation system
Wound & Skin Hydrogel OTC
Seriously Clean, Ltd.
221Z1
In Commercial Distribution

  • 00851608007539 ()


  • Antimicrobial wound irrigation solution
Control Module,Kavo,OTC
A-DEC, INC.
54.0809.01
In Commercial Distribution

  • 10194665005450 ()
54.0809.01

  • Remotely-driven surgical/dental system drive cable
OTC Rechargeable Hearing Aid
Audicon Corporation
Torch
In Commercial Distribution

  • 10860010331078 ()
  • 00860010331071 ()


  • Air-conduction hearing aid, in-the-ear
OTC Rechargeable Hearing Aid
Audicon Corporation
Solid
In Commercial Distribution

  • 10860010331061 ()
  • 00860010331064 ()


  • Air-conduction hearing aid, behind-the-ear
OTC Rechargeable Hearing Aid
Audicon Corporation
Style
In Commercial Distribution

  • 00860010331057 ()
  • 10860010331054 ()


  • Air-conduction hearing aid, in-the-ear
OTC Rechargeable Hearing Aid
Audicon Corporation
Fusion
In Commercial Distribution

  • 00860010331026 ()
  • 10860010331023 ()
  • 20860010331020 ()
  • 40860010331024 ()


  • Air-conduction hearing aid, in-the-ear
Finger Pulse Oximeter, OTC
COMPASS HEALTH BRANDS CORP.
50052
Not in Commercial Distribution

  • 80092237604591 ()
  • 00092237604595 ()


  • Pulse oximeter probe, reusable
Finger Pulse Oximeter, OTC
COMPASS HEALTH BRANDS CORP.
50052
Not in Commercial Distribution

  • 00092237604595 ()
  • 30815067013372 ()
  • 00815067013371 ()


  • Pulse oximeter probe, reusable
OTC Primer 1.5ml Bottle
PARKELL, INC.
S826
Not in Commercial Distribution

  • M595S8260 ()
S826

  • Denture reliner, soft, professional
Mepore 9x15cm OTC Norden
Mölnlycke Health Care AB
671000
In Commercial Distribution

  • 07323190254385 ()
  • 07323190254842 ()
  • 07323190254378 ()

  • 9cm x 15cm


  • Adhesive bandage
Lucid® FIO OTC
HEARING LAB TECHNOLOGY, LLC
7287
In Commercial Distribution

  • 00810068830446 ()
HLT-FIO

  • Air-conduction hearing aid, canal
Engage Android OTC Grey
HEARING LAB TECHNOLOGY, LLC
7495
In Commercial Distribution

  • 00810068831481 ()
10094

  • Air-conduction hearing aid, receiver-in-the-ear
Engage MFI OTC Grey
HEARING LAB TECHNOLOGY, LLC
7595
In Commercial Distribution

  • 00810068831474 ()
10093

  • Air-conduction hearing aid, receiver-in-the-ear
Engage Android OTC Black
HEARING LAB TECHNOLOGY, LLC
7495
In Commercial Distribution

  • 00810068831467 ()
10092

  • Air-conduction hearing aid, receiver-in-the-ear
Engage MFI OTC Black
HEARING LAB TECHNOLOGY, LLC
7595
In Commercial Distribution

  • 00810068831450 ()
10091

  • Air-conduction hearing aid, receiver-in-the-ear
Enrich Pro BTE OTC
HEARING LAB TECHNOLOGY, LLC
Enrich Pro BTE
In Commercial Distribution

  • 00810068831443 ()
10082

  • Air-conduction hearing aid acoustic tube
Engage Android OTC Beige
HEARING LAB TECHNOLOGY, LLC
7495
In Commercial Distribution

  • 00810068831399 ()
10077

  • Air-conduction hearing aid, receiver-in-the-ear
Engage MFI OTC Beige
HEARING LAB TECHNOLOGY, LLC
7595
In Commercial Distribution

  • 00810068831382 ()
10076

  • Air-conduction hearing aid, receiver-in-the-ear
OTC Rechargeable Hearing Aid
Audicon Corporation
Essential
In Commercial Distribution

  • 10860010331009 ()
  • 00860010331002 ()
CE-A39HT(White)

  • Air-conduction hearing aid, in-the-ear
OTC Rechargeable Hearing Aid
Audicon Corporation
Core One Pro
In Commercial Distribution

  • 10850065321308 ()
  • 00850065321301 ()
CE-A90A(White)

  • Air-conduction hearing aid, in-the-ear
OTC Rechargeable Hearing Aid
Audicon Corporation
Core One Pro
In Commercial Distribution

  • 10850065321292 ()
  • 00850065321295 ()
CE-A90A(Black)

  • Air-conduction hearing aid, in-the-ear
OTC Rechargeable Hearing Aid
Audicon Corporation
Core One Pro
In Commercial Distribution

  • 10850065321261 ()
  • 00850065321264 ()
CE-A90A(skin)

  • Air-conduction hearing aid, in-the-ear
Hearing Test Feature AirPods Pro 2 Firmware (1.X)
APPLE INC.
Feature version 1.X
In Commercial Distribution

  • 00195949149955 ()


  • Self-testing tone audiometer
Hearing Test Feature iOS (1.X)
APPLE INC.
Feature version 1.X
In Commercial Distribution

  • 00195949149948 ()


  • Self-testing tone audiometer
No Description
SMD Solution Co.,Ltd.
DCC1WA1A
In Commercial Distribution

  • 08800201500024 ()


  • Oral lavage system
Cavitron® Steri-Mate® Handpiece Sterile Lavage Adapter
Dentsply Professional
81345
Not in Commercial Distribution

  • D003813451 ()


  • Oral lavage system
Cavitron® Steri-Mate® Handpiece Sterile Lavage Kit. Contains: Infuser Bag, and Adapter.
Dentsply Professional
81340
Not in Commercial Distribution

  • D003813401 ()


  • Oral lavage system
UPLIFT PREMIUM POWER LIFTING SEAT, 20"
COMPASS HEALTH BRANDS CORP.
CCFPS3020
In Commercial Distribution

  • 00627394121113 ()


  • Lifting seat cushion
UPLIFT PREMIUM POWER LIFTING SEAT, 17"
COMPASS HEALTH BRANDS CORP.
CCFPS3017
In Commercial Distribution

  • 00627394121014 ()


  • Lifting seat cushion
UPEASY SEAT ASSIST, PLUS
COMPASS HEALTH BRANDS CORP.
CCFUPE3
In Commercial Distribution

  • 00627394995332 ()


  • Lifting seat cushion
UPEASY SEAT ASSIST, STANDARD
COMPASS HEALTH BRANDS CORP.
CCFUPE1
In Commercial Distribution

  • 00627394995318 ()


  • Lifting seat cushion
UPEASY POWER SEAT
COMPASS HEALTH BRANDS CORP.
CCFUPEP100
In Commercial Distribution

  • 00627394701025 ()


  • Lifting seat cushion
UPLIFT PREMIUM SEAT ASSIST, PLUS
COMPASS HEALTH BRANDS CORP.
CCFMEDUL300
In Commercial Distribution

  • 00627394213016 ()


  • Lifting seat cushion
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