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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Engage Android OTC Rechargeable Beige
HEARING LAB TECHNOLOGY, LLC
7495
In Commercial Distribution

  • 00810068831429 ()
10080

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

  • 00810068831412 ()
10079

  • Air-conduction hearing aid, receiver-in-the-ear
Enrich Pro ITC OTC Pair
HEARING LAB TECHNOLOGY, LLC
9486/9487
In Commercial Distribution

  • 00810068831405 ()
10078

  • Air-conduction hearing aid, canal
DRX-Evolution Plus Transbay OTC System
CARESTREAM HEALTH, INC.
DRX-Evolution Plus System
In Commercial Distribution

  • 60889971739469 ()
1739465

  • Stationary basic diagnostic x-ray system, digital
Wound Cleanser OTC 8 oz
Pure & Clean, LLC
None
Not in Commercial Distribution

  • 00739189359158 ()

  • Total Volume: 8 Fluid Ounce
1WC8

  • Antimicrobial wound irrigation solution
C Series Foam Electrode O-T-C
Cardinal Health, Inc.
EP85887
In Commercial Distribution

  • 00884521582210 ()
  • 00884521582203 ()
  • 00884521746100 ()

  • Outer Diameter: 2.75 Inch
EP85887

  • Transcutaneous electrical stimulation electrode, single-use
C Series Foam Electrode O-T-C
Cardinal Health, Inc.
EP85881
In Commercial Distribution

  • 00884521582173 ()
  • 00884521582166 ()
  • 00884521746100 ()

  • Outer Diameter: 2 Inch
EP85881

  • Transcutaneous electrical stimulation electrode, single-use
C Series Spunlace Electrodes O-T-C
Cardinal Health, Inc.
EP85875
Not in Commercial Distribution

  • 00884521582111 ()
  • 00884521582104 ()
  • 00884521746124 ()

  • Length: 2 Inch
  • Width: 2 Inch
EP85875

  • Transcutaneous electrical stimulation electrode, single-use
C Series Spunlace Electrodes O-T-C
Cardinal Health, Inc.
EP85873
Not in Commercial Distribution

  • 00884521582098 ()
  • 00884521582081 ()
  • 00884521746117 ()

  • Width: 2.5 Inch
  • Length: 1.5 Inch
EP85873

  • Transcutaneous electrical stimulation electrode, single-use
C Series Spunlace Electrodes O-T-C
Cardinal Health, Inc.
EP85869
In Commercial Distribution

  • 00884521582074 ()
  • 00884521582067 ()
  • 00884521746100 ()

  • Outer Diameter: 2.75 Inch
EP85869

  • Transcutaneous electrical stimulation electrode, single-use
C Series Stimulating Electrodes O-T-C
Cardinal Health, Inc.
EP85861
In Commercial Distribution

  • 00884521582036 ()
  • 00884521582029 ()
  • 00884521746162 ()

  • Outer Diameter: 2 Inch
EP85861

  • Transcutaneous electrical stimulation electrode, single-use
C Series Stimulating Electrodes O-T-C
Cardinal Health, Inc.
EP85860
In Commercial Distribution

  • 00884521581992 ()
  • 00884521581985 ()
  • 00884521746100 ()

  • Outer Diameter: 1.25 Inch
EP85860

  • Transcutaneous electrical stimulation electrode, single-use
C Series Foam Electrode O-T-C
Cardinal Health, Inc.
EP85883
In Commercial Distribution

  • 00884521582197 ()
  • 00884521582180 ()
  • 00884521746100 ()

  • Width: 3.5 Inch
  • Length: 2 Inch
EP85883

  • Transcutaneous electrical stimulation electrode, single-use
C Series Foam Electrode O-T-C
Cardinal Health, Inc.
EP85879
In Commercial Distribution

  • 00884521582159 ()
  • 00884521582142 ()
  • 00884521746148 ()

  • Width: 2 Inch
  • Length: 2 Inch
EP85879

  • Transcutaneous electrical stimulation electrode, single-use
C Series Foam Electrode O-T-C
Cardinal Health, Inc.
EP85877
In Commercial Distribution

  • 00884521582135 ()
  • 00884521582128 ()
  • 00884521746131 ()

  • Outer Diameter: 1.25 Inch
EP85877

  • Transcutaneous electrical stimulation electrode, single-use
C Series Spunlace Electrodes O-T-C
Cardinal Health, Inc.
EP85867
In Commercial Distribution

  • 00884521582050 ()
  • 00884521582043 ()
  • 00884521746100 ()

  • Length: 2 Inch
  • Width: 3.5 Inch
EP85867

  • Transcutaneous electrical stimulation electrode, single-use
C Series Stimulating Electrodes O-T-C
Cardinal Health, Inc.
EP85863
In Commercial Distribution

  • 00884521582012 ()
  • 00884521582005 ()
  • 00884521746155 ()

  • Width: 2 Inch
  • Length: 2 Inch
EP85863

  • Transcutaneous electrical stimulation electrode, single-use
No Description
Sonoma Pharmaceuticals, Inc.
P-E1175T00
In Commercial Distribution

  • 20860000883355 ()
  • 00860000883351 ()

  • Total Volume: 500 Milliliter
P-E1175T00

  • Non-antimicrobial wound irrigation solution, multiple solute
No Description
Sonoma Pharmaceuticals, Inc.
P-E1174T00
In Commercial Distribution

  • 20860000883348 ()
  • 00860000883344 ()

  • Total Volume: 250 Milliliter
P-E1174T00

  • Non-antimicrobial wound irrigation solution, multiple solute
BEIGE/990013-SWH; right replacement for Sontro Self-Fitting OTC Hearing Aids (Model: AI); self-fit, app-controlled hearing aids
Soundwave Hearing, LLC
990013-SWH
In Commercial Distribution

  • 00850016231130 ()


  • Air-conduction hearing aid, receiver-in-canal
BEIGE/990011-SWH; set of Sontro Self-Fitting OTC Hearing Aids (Model: AI); self-fit, app-controlled hearing aids
Soundwave Hearing, LLC
990011-SWH
In Commercial Distribution

  • 00850016231116 ()


  • Air-conduction hearing aid, receiver-in-canal
BEIGE/990035-SWH; set of Sontro Self-Fitting OTC Hearing Aids (Model AI-S); self-fit, streaming, app-controlled hearing aids
Soundwave Hearing, LLC
990035-SWH
In Commercial Distribution

  • 00850016231109 ()


  • Air-conduction hearing aid, receiver-in-canal
GREY/990008-SWH; left (refurbished) replacement for Sontro Self-Fitting OTC Hearing Aids (Model: AI); self-fit, app-controlled hearing aids
Soundwave Hearing, LLC
990008-SWH
In Commercial Distribution

  • 00850016231086 ()


  • Air-conduction hearing aid, receiver-in-canal
GREY/990007-SWH; right (refurbished) replacement for Sontro Self-Fitting OTC Hearing Aids (Model: AI); self-fit, app-controlled hearing aids
Soundwave Hearing, LLC
990007-SWH
In Commercial Distribution

  • 00850016231079 ()


  • Air-conduction hearing aid, receiver-in-canal
GREY/990005-SWH; left replacement for Sontro Self-Fitting OTC Hearing Aids (Model: AI); self-fit, app-controlled hearing aids
Soundwave Hearing, LLC
990005-SWH
In Commercial Distribution

  • 00850016231055 ()


  • Air-conduction hearing aid, receiver-in-canal
GREY/990004-SWH; right replacement for Sontro Self-Fitting OTC Hearing Aids (Model: AI); self-fit, app-controlled hearing aids
Soundwave Hearing, LLC
990004-SWH
In Commercial Distribution

  • 00850016231048 ()


  • Air-conduction hearing aid, receiver-in-canal
GREY/990002-SWH; set of Sontro Self-Fitting OTC Hearing Aids (Model: AI); self-fit, app-controlled hearing aids
Soundwave Hearing, LLC
990002-SWH
In Commercial Distribution

  • 00850016231024 ()


  • Air-conduction hearing aid, receiver-in-canal
GREY/990030-SWH; set of Sontro Self-Fitting OTC Hearing Aids (Model AI-S); self-fit, streaming, app-controlled hearing aids
Soundwave Hearing, LLC
990030-SWH
In Commercial Distribution

  • 00850016231000 ()


  • Air-conduction hearing aid, receiver-in-canal
BEIGE/990017-SWH; left (refurbished) replacement for Sontro Self-Fitting OTC Hearing Aids (Model: AI); self-fit, app-controlled hearing aids
Soundwave Hearing, LLC
990017-SWH
In Commercial Distribution

  • 00850016231178 ()


  • Air-conduction hearing aid, receiver-in-canal
BEIGE/990016-SWH; right (refurbished) replacement for Sontro Self-Fitting OTC Hearing Aids (Model: AI); self-fit, app-controlled hearing aids
Soundwave Hearing, LLC
990016-SWH
In Commercial Distribution

  • 00850016231161 ()


  • Air-conduction hearing aid, receiver-in-canal
BEIGE/990014-SWH; left replacement for Sontro Self-Fitting OTC Hearing Aids (Model: AI); self-fit, app-controlled hearing aids
Soundwave Hearing, LLC
990014-SWH
In Commercial Distribution

  • 00850016231147 ()


  • Air-conduction hearing aid, receiver-in-canal
ChitoGauze is intended for temporary external use to stop bleeding in minor wounds.
TRICOL BIOMEDICAL, INC.
1
In Commercial Distribution

  • 50870053000303 ()
  • 00870053000308 ()
1025

  • Chitosan haemostatic agent, professional, non-bioabsorbable
Wound Irrigation
Bionix, LLC
601
Not in Commercial Distribution

  • 20859911004027 ()
  • 00859911004023 ()
601

  • Wound shield
Porcelain Powder for clinical use.
Kulzer GmbH
66008770
Not in Commercial Distribution

  • J014660155890 ()
66008770

  • Dental appliance fabrication material, ceramic
InTENSity Mini Pack Eletrodes 2x2 white cloth 4/pk OTC
COMPASS HEALTH BRANDS CORP.
EP2020WC2-INTM-2
In Commercial Distribution

  • 00092237623916 ()


  • Transcutaneous electrical stimulation electrode, single-use
6mL NeoConnect Enteral Syringe with ENFit Connector, Non-Sterile, OTC
NEOMED, INC.
Neo6
In Commercial Distribution

  • 20817584013210 ()
  • 10817584013213 ()
  • 00817584013216 ()
Neo6

  • ENFit oral/enteral syringe, reusable
3mL NeoConnect Enteral Syringe with ENFit Connector, Non-Sterile, OTC
NEOMED, INC.
Neo3
In Commercial Distribution

  • 20817584013203 ()
  • 10817584013206 ()
  • 00817584013209 ()
Neo3

  • ENFit oral/enteral syringe, reusable
60mL NeoConnect Enteral Syringe with ENFit Connector, Non-Sterile, OTC
NEOMED, INC.
Neo60
In Commercial Distribution

  • 10817584013237 ()
  • 00817584013230 ()
  • 20817584013234 ()
Neo60

  • ENFit oral/enteral syringe, reusable
12mL NeoConnect Enteral Syringe with ENFit Connector, Non-Sterile, OTC
NEOMED, INC.
Neo12
In Commercial Distribution

  • 20817584013227 ()
  • 10817584013220 ()
  • 00817584013223 ()
Neo12

  • ENFit oral/enteral syringe, reusable
No Description
Sonoma Pharmaceuticals, Inc.
84873
In Commercial Distribution

  • 20189116000068 ()
  • 00189116000064 ()

  • Total Volume: 237 Milliliter
84873

  • Non-antimicrobial wound irrigation solution, multiple solute
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