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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BTE OTC Hearing Aids, Pair - Charcoal
Novidan, Inc.
99-0019-03
In Commercial Distribution

  • 00850049194129 ()


  • Air-conduction hearing aid, behind-the-ear
BTE OTC Hearing Aids, Pair - Slate
Novidan, Inc.
99-0019-02
In Commercial Distribution

  • 00850049194112 ()


  • Air-conduction hearing aid, behind-the-ear
BTE OTC Hearing Aids, Pair - Beige
Novidan, Inc.
99-0019-01
In Commercial Distribution

  • 00850049194105 ()


  • Air-conduction hearing aid, behind-the-ear
Safer Lock - Rx Locking Cap OTC
Rxguardian Inc.
1000092
In Commercial Distribution

  • 00860002613611 ()


  • Medicine bottle
  • Medicine bottle cap
FEEDING SYRINGE, ENFIT, FLT TP, OTC
MEDLINE INDUSTRIES, INC.
ENFIT70660
In Commercial Distribution

  • 40193489036658 ()
  • 00193489036650 ()
ENFIT70660

  • ENFit oral/enteral syringe, single-use
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
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
OTC Single Use urinary test strip
REESE PHARMACEUTICAL COMPANY
UTES
In Commercial Distribution

  • 00023513487441 ()


  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical
OTC Single Use urinary test strip
REESE PHARMACEUTICAL COMPANY
UTES
In Commercial Distribution

  • 00023513000039 ()
  • 00036800468450 ()


  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical
Procellera Single Layer OTC, 2"x2"
Vomaris Wound Care, Inc.
2"x 2"
In Commercial Distribution

  • 00810198030372 ()
VSC-0202

  • Bioelectric wound dressing
Mepilex Border Lite 10x10cm, OTC US
Mölnlycke Health Care AB
281300
In Commercial Distribution

  • 07323190049165 ()
  • 07332430529022 ()
  • 07323190049158 ()

  • 10cm x 10cm


  • 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 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 Flex 10x10cm, OTC US
Mölnlycke Health Care AB
595333
In Commercial Distribution

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

  • 10x10cm


  • Wound-nonadherent dressing, absorbent, non-antimicrobial
Quell 2.0 Relief Replacement Device (OTC)
NEUROMETRIX, INC.
QE-NAS-RPL
In Commercial Distribution

  • 00851221006803 ()


  • Analgesic transcutaneous electrical nerve stimulation system
It is hair grow system for OTC
Xuzhou Kernel Medical Equipment Co., Ltd.
KN-8000B
In Commercial Distribution

  • 06928798600353 ()


  • Hair growth laser device
Wound Solutions Wound Cleanser OTC 8 oz
Pure & Clean, LLC
2-25-20
In Commercial Distribution

  • 00852421007515 ()

  • Total Volume: 8 Fluid Ounce
11WC8-Z

  • Antimicrobial wound irrigation solution
Wound Solutions Wound Cleanser OTC 2 oz
Pure & Clean, LLC
2-25-20
In Commercial Distribution

  • 00852421007508 ()

  • Total Volume: 2 Fluid Ounce
11WC2-Z

  • Antimicrobial wound irrigation solution
Tubing,Controller Motor,Long,A-dec 501,OTC
A-DEC, INC.
54.0854.00
In Commercial Distribution

  • 10194665005597 ()
54.0854.00

  • Remotely-driven surgical/dental system drive cable
Tubing,Controller Motor,Short,A-dec 501,OTC
A-DEC, INC.
54.0852.00
In Commercial Distribution

  • 10194665005542 ()
54.0852.00

  • Remotely-driven surgical/dental system drive cable
Air LS Package,A11,Class A,OTC
A-DEC, INC.
54.0879.001
In Commercial Distribution

  • 10194665005528 ()
54.0879.00

  • Remotely-driven surgical/dental system drive cable
Kit,Tubing ASSY,Long,A-dec 501,OTC
A-DEC, INC.
54.0798.01
In Commercial Distribution

  • 10194665005498 ()
54.0798.01

  • Remotely-driven surgical/dental system drive cable
Kit,Tubing ASSY,Medium,A-dec 501,OTC
A-DEC, INC.
54.0797.01
In Commercial Distribution

  • 10194665005481 ()
54.0797.01

  • Remotely-driven surgical/dental system drive cable
CVRSN Kit,Dual HVE,Durr HVE,OTC
A-DEC, INC.
90.1287.00
In Commercial Distribution

  • 10194665005009 ()
90.1287.00

  • Dental suction system
Electric HS Package,M25L,Master Matic,OTC
A-DEC, INC.
54.0882.00
In Commercial Distribution

  • 10194665004538 ()
54.0882.00

  • Pneumatic dental power tool system handpiece tip, reusable
Electric HS Package,E25L,Expert Matic,OTC
A-DEC, INC.
54.0881.00
In Commercial Distribution

  • 10194665004521 ()
54.0881.00

  • Pneumatic dental power tool system handpiece tip, reusable
Air LS Package,181P,Prophy Wiz,OTC
A-DEC, INC.
54.0880.00
In Commercial Distribution

  • 10194665004514 ()
54.0880.00

  • Pneumatic dental power tool system handpiece tip, reusable
Air LS Package,S20K,Smart Matic,OTC
A-DEC, INC.
54.0878.00
In Commercial Distribution

  • 10194665004507 ()
54.0878.00

  • Pneumatic dental power tool system handpiece tip, reusable
Air HS Package,E679L,Expert Torque,OTC
A-DEC, INC.
54.0877.00
In Commercial Distribution

  • 10194665004491 ()
54.0877.00

  • Pneumatic dental power tool system handpiece tip, reusable
Air HS Package,M8700L,Master Torque,OTC
A-DEC, INC.
54.0876.00
In Commercial Distribution

  • 10194665004484 ()
54.0876.00

  • Pneumatic dental power tool system handpiece tip, reusable
Air HS Package,M8900L,Master Torque,OTC
A-DEC, INC.
54.0875.00
In Commercial Distribution

  • 10194665004477 ()
54.0875.00

  • Pneumatic dental power tool system handpiece tip, reusable
Electric LS Package,M20L,Master Matic,OTC
A-DEC, INC.
54.0865.00
In Commercial Distribution

  • 10194665004460 ()
54.0865.00

  • Barbed polyolefin suture
Pro Rechargeable OTC Hearing Aids - Graphite Pair
Novidan, Inc.
99-0017-06
In Commercial Distribution

  • 00850049194457 ()


  • Air-conduction hearing aid, receiver-in-canal
Pro Rechargeable OTC Hearing Aids - Beige Pair
Novidan, Inc.
99-0017-05
In Commercial Distribution

  • 00850049194440 ()


  • Air-conduction hearing aid, receiver-in-canal
Pro Rechargeable OTC Hearing Aids - Glacier Pair
Novidan, Inc.
99-0017-04
In Commercial Distribution

  • 00850049194433 ()


  • Air-conduction hearing aid, receiver-in-canal
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