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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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.
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
Mepore Pro 9x15cm OTC Norden
Mölnlycke Health Care AB
671090
In Commercial Distribution

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

  • 9cm x 15cm


  • Adhesive bandage
Mepiform OTC 10x18, non sterile
Mölnlycke Health Care AB
293800
In Commercial Distribution

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

  • 10cm x 18cm


  • Scar-management dressing, single-use
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
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
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
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