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

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

  • 9cm x 15cm


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

  • 00739189359158 ()

  • Total Volume: 8 Fluid Ounce
1WC8

  • Antimicrobial wound irrigation solution
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
No Description
Sonoma Pharmaceuticals, Inc.
86005
In Commercial Distribution

  • 20850015491492 ()
  • 00850015491498 ()

  • Total Volume: 59 Milliliter
86005

  • Non-antimicrobial wound irrigation solution, multiple solute
No Description
Sonoma Pharmaceuticals, Inc.
86012
In Commercial Distribution

  • 20850015491676 ()
  • 00850015491672 ()

  • Total Volume: 118 Milliliter
86012

  • Non-antimicrobial wound irrigation solution, multiple solute
ChitoGauze is intended for temporary external use to stop bleeding in minor wounds.
TRICOL BIOMEDICAL, INC.
1
In Commercial Distribution

  • 50870053000297 ()
  • 00870053000292 ()
1030

  • Chitosan haemostatic agent, professional, non-bioabsorbable
Mini-kit
TOKUYAMA DENTAL CORPORATION
15141
In Commercial Distribution

  • 04548190151417 ()


  • Dental cavity varnish
  • Dental coating, tooth-desensitizing
Refill
TOKUYAMA DENTAL CORPORATION
15121
In Commercial Distribution

  • 04548190151219 ()


  • Dental coating, tooth-desensitizing
  • Dental cavity varnish
Kit
TOKUYAMA DENTAL CORPORATION
15111
In Commercial Distribution

  • 04548190151110 ()


  • Dental cavity varnish
  • Dental coating, tooth-desensitizing
Mepilex Border Lite 7,5x7,5cm, OTC US
Mölnlycke Health Care AB
281200
In Commercial Distribution

  • 07323190048892 ()
  • 07332430529008 ()
  • 07323190048885 ()

  • 7.5cm x 7.5cm


  • Wound-nonadherent dressing, absorbent, non-antimicrobial
Mepilex Border Lite 4x5cm, OTC US
Mölnlycke Health Care AB
281000
In Commercial Distribution

  • 07323190246618 ()
  • 07323190246625 ()
  • 07332430520395 ()

  • 4cm x 5cm


  • Wound-nonadherent dressing, absorbent, non-antimicrobial
Mepilex Border Flex 10x10cm, OTC US
Mölnlycke Health Care AB
595333
In Commercial Distribution

  • 07333350089757 ()
  • 07333350881245 ()
  • 07333350732097 ()

  • 10x10cm


  • Wound-nonadherent dressing, absorbent, non-antimicrobial
Procellera Single Layer OTC, 2"x2"
Vomaris Wound Care, Inc.
2"x 2"
In Commercial Distribution

  • 00810198030372 ()
VSC-0202

  • Bioelectric wound dressing
OTC, HEARING AID, BEHIND EAR, WT
MEDLINE INDUSTRIES, INC.
MDSHEARAIDWT1
In Commercial Distribution

  • 00197344013275 ()

  • Width: 10.5 Millimeter
  • Length: 33.1 Millimeter
  • MDSHEARAIDWT
MDSHEARAIDWT1

  • Air-conduction hearing aid, behind-the-ear
OTC, HEARING AID, IN EAR, BLACK
MEDLINE INDUSTRIES, INC.
MDSHEARAIDBK1
In Commercial Distribution

  • 20197344013248 ()
  • 00197344013244 ()
  • 80197344013240 ()
MDSHEARAIDBK1

  • Air-conduction hearing aid, in-the-ear
Lucid Hearing OTC Hearing Protection #20055
ETYMOTIC RESEARCH, INC.
Lucid Hearing OTC #20055
In Commercial Distribution

  • 00846430005662 ()


  • Earplugs, reusable
QuikClot Bleeding Control Bag, OTC,SOFTT-W
Z-MEDICA, LLC
0622
In Commercial Distribution

  • 00841495106224 ()
0622

  • Non-organic haemostatic agent
QuikClot Bleeding Control Bag, OTC, CAT
Z-MEDICA, LLC
0621
In Commercial Distribution

  • 00841495106217 ()
0621

  • Non-organic haemostatic agent
QuikClot Bleeding Control Kit, OTC, SOFTT-W
Z-MEDICA, LLC
0612
In Commercial Distribution

  • 00841495106125 ()
0612

  • Non-organic haemostatic agent
QuikClot Bleeding Control Kit, OTC, CAT
Z-MEDICA, LLC
0611
In Commercial Distribution

  • 00841495106118 ()
0611

  • Non-organic haemostatic agent
FEEDING SYRINGE, ENFIT, FLT TP, OTC
MEDLINE INDUSTRIES, INC.
ENFIT70660
In Commercial Distribution

  • 40193489036658 ()
  • 00193489036650 ()
ENFIT70660

  • ENFit oral/enteral syringe, single-use
Safer Lock - Rx Locking Cap OTC
Rxguardian Inc.
1000092
In Commercial Distribution

  • 00860002613611 ()


  • Medicine bottle
  • Medicine bottle cap
1T, FDA OTC, Without Absorbent wick
Hangzhou AllTest Biotech Co., Ltd.
1
In Commercial Distribution

  • 06936983155151 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
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