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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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.
EP85863
In Commercial Distribution

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

  • Width: 2 Inch
  • Length: 2 Inch
EP85863

  • 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
Wound Cleanser OTC 8 oz
Pure & Clean, LLC
None
Not in Commercial Distribution

  • 00739189359158 ()

  • Total Volume: 8 Fluid Ounce
1WC8

  • Antimicrobial wound irrigation solution
Wound Cleanser OTC 2 oz
Pure & Clean, LLC
2.20
In Commercial Distribution

  • 00852421007188 ()

  • Total Volume: 2 Fluid Ounce
1WC2

  • Antimicrobial wound irrigation solution
Wound Cleanser OTC 8 oz
Pure & Clean, LLC
23.07
In Commercial Distribution

  • 00852421007027 ()

  • Total Volume: 8 Fluid Ounce
1WC8

  • Antimicrobial wound irrigation solution
1T,EN,FDA, OTC,1ng
Hangzhou AllTest Biotech Co., Ltd.
DFY-A102H A3218
In Commercial Distribution

  • 06936983149426 ()
ID-AT1-DIP-FEN-1-AZ1

  • Fentanyl IVD, kit, rapid ICT, clinical
Tubing,Motor,Long,Kavo,OTC
A-DEC, INC.
54.0847.01
In Commercial Distribution

  • 10194665004170 ()
54.0847.01

  • Dental surgical power tool motor, electric
Tubing,Motor,Medium,Kavo,OTC
A-DEC, INC.
54.0846.01
In Commercial Distribution

  • 10194665004156 ()
54.0846.01

  • Dental surgical power tool motor, electric
TopTENS OTC Electrodes (2 x2
COMPASS HEALTH BRANDS CORP.
E1P2020BC2-TT
In Commercial Distribution

  • 80092237616174 ()
  • 30092237616179 ()
  • 00092237616178 ()
  • 01092237616177 ()


  • Transcutaneous electrical stimulation electrode, single-use
OTC hearing aids, behind-the-ear design
Voxx Accessories Corp.
RSH053SL
In Commercial Distribution

  • 00044476158056 ()


  • Air-conduction hearing aid, behind-the-ear
OTC hearing aids, behind-the-ear design
Voxx Accessories Corp.
RSH053BG
In Commercial Distribution

  • 00044476158049 ()


  • Air-conduction hearing aid, behind-the-ear
OTC hearing aid, behind-the-ear design
Voxx Accessories Corp.
RSH05BK
In Commercial Distribution

  • 00044476153167 ()


  • Air-conduction hearing aid, behind-the-ear
OTC hearing aid, behind-the-ear design
Voxx Accessories Corp.
RSH05GY
In Commercial Distribution

  • 00044476153150 ()


  • Air-conduction hearing aid, behind-the-ear
OTC hearing aid, behind-the-ear design
Voxx Accessories Corp.
RSH05BG
In Commercial Distribution

  • 00044476153143 ()


  • Air-conduction hearing aid, behind-the-ear
Procellera FLexEFit OTC, 2.5"x6.3"
Vomaris Wound Care, Inc.
2.5"x6.3"
In Commercial Distribution

  • 00810198031140 ()
VFC-2563

  • Bioelectric wound dressing
Procellera Composite OTC; 4' diameter
Vomaris Wound Care, Inc.
4" Diam
In Commercial Distribution

  • 00810198030419 ()
VHC-D04

  • Bioelectric wound dressing
Procellera Composite OTC; 4"x4"
Vomaris Wound Care, Inc.
4"x4"
In Commercial Distribution

  • 00810198030402 ()
VHC-0404

  • Bioelectric wound dressing
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
Mepiform OTC 10x18, non sterile
Mölnlycke Health Care AB
293800
In Commercial Distribution

  • 07323190179251 ()
  • 07323190179268 ()
  • 07332430998903 ()

  • 10cm x 18cm


  • Scar-management dressing, single-use
Mepore Pro 9x15cm OTC Norden
Mölnlycke Health Care AB
671090
In Commercial Distribution

  • 07323190253050 ()
  • 07323190254040 ()
  • 07323190253043 ()

  • 9cm x 15cm


  • Adhesive bandage
Engage Android OTC Rechargeable Grey
HEARING LAB TECHNOLOGY, LLC
7495
In Commercial Distribution

  • 00810068831528 ()
10098

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

  • 00810068831511 ()
10097

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

  • 00810068831504 ()
10096

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

  • 00810068831498 ()
10095

  • Air-conduction hearing aid, receiver-in-the-ear
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
QuickVue At-Home OTC COVID-19 Test
QUIDEL CORPORATION
20402
In Commercial Distribution

  • 30014613339724 ()
20402

  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
QuickVue At-Home OTC COVID-19 Test
QUIDEL CORPORATION
20399
In Commercial Distribution

  • 30014613339687 ()
20399

  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
QuickVue At-Home OTC COVID-19 Test
QUIDEL CORPORATION
20398
In Commercial Distribution

  • 30014613339670 ()
20398

  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
OTC DEVICE TO TREAT WRINKLES
zhongshan Bisen plastic electronic products CO,LTD
900
Not in Commercial Distribution

  • 26928336800386 ()
  • 16928336800389 ()


  • Cosmetic red-light phototherapy system, home-use
OTC DEVICE TO TREAT WRINKLES
zhongshan Bisen plastic electronic products CO,LTD
850
Not in Commercial Distribution

  • 26928336800379 ()
  • 16928336800372 ()


  • Cosmetic red-light phototherapy system, home-use
OTC DEVICE TO TREAT WRINKLES
zhongshan Bisen plastic electronic products CO,LTD
700 BLACK
Not in Commercial Distribution

  • 26928336800362 ()
  • 16928336800365 ()


  • Cosmetic red-light phototherapy system, home-use
OTC DEVICE TO TREAT WRINKLES
zhongshan Bisen plastic electronic products CO,LTD
700 PINK
Not in Commercial Distribution

  • 16928336800358 ()
  • 26928336800355 ()


  • Cosmetic red-light phototherapy system, home-use
Porcelain Powder for clinical use.
Kulzer GmbH
66008770
Not in Commercial Distribution

  • J014660155890 ()
66008770

  • Dental appliance fabrication material, ceramic
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
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