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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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
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
Wound Irrigation
Bionix, LLC
601
Not in Commercial Distribution

  • 20859911004027 ()
  • 00859911004023 ()
601

  • Wound shield
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
No Description
Sonoma Pharmaceuticals, Inc.
84873
In Commercial Distribution

  • 20189116000068 ()
  • 00189116000064 ()

  • Total Volume: 237 Milliliter
84873

  • Non-antimicrobial wound irrigation solution, multiple solute
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
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
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
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
Finger Pulse Oximeter, OTC
COMPASS HEALTH BRANDS CORP.
50052
Not in Commercial Distribution

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


  • Pulse oximeter probe, reusable
STERILE OTC BASIC PACK
Cardinal Health 200, LLC
SBA5CBPGSB
In Commercial Distribution

  • 50887488789840 ()
  • 10887488789842 ()
SBA5CBPGSB

  • General surgical procedure kit, non-medicated, single-use
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
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