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 Single Use urinary test strip
REESE PHARMACEUTICAL COMPANY
UTES
In Commercial Distribution

  • 00023513487441 ()


  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical
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
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 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
OTC, HEARING AID, BEHIND EAR, BT, WT
MEDLINE INDUSTRIES, INC.
MDSHEARAIDWT2
In Commercial Distribution

  • 00197344013282 ()

  • MDSHEARAIDWT
  • Width: 10.5 Millimeter
  • Length: 33.1 Millimeter
MDSHEARAIDWT2

  • Air-conduction hearing aid, behind-the-ear
OTC, HEARING AID, IN EAR, BT, BLACK
MEDLINE INDUSTRIES, INC.
MDSHEARAIDBK2
In Commercial Distribution

  • 20197344013255 ()
  • 00197344013251 ()
MDSHEARAIDBK2

  • Air-conduction hearing aid, in-the-ear
Tala Charger for Tala OTC Hearing Aid
ETYMOTIC RESEARCH, INC.
TALA CHARGER
In Commercial Distribution

  • 00846430005860 ()


  • Air-conduction hearing aid, in-the-ear
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
NoviOne BTE OTC Hearing Aids, Pair - Charcoal
Novidan, Inc.
99-0002-25
In Commercial Distribution

  • 00850049194273 ()


  • Air-conduction hearing aid, behind-the-ear
NoviOne BTE OTC Hearing Aids, Pair - Slate
Novidan, Inc.
99-0002-24
In Commercial Distribution

  • 00850049194266 ()


  • Air-conduction hearing aid, behind-the-ear
NoviOne BTE OTC Hearing Aids, Pair - Beige
Novidan, Inc.
99-0002-23
In Commercial Distribution

  • 00850049194259 ()


  • Air-conduction hearing aid, behind-the-ear
NoviOne RIC OTC Hearing Aids, Pair - Charcoal
Novidan, Inc.
99-0001-16
In Commercial Distribution

  • 00850049194242 ()


  • Air-conduction hearing aid, receiver-in-canal
NoviOne RIC OTC Hearing Aids, Pair - Slate
Novidan, Inc.
99-0001-15
In Commercial Distribution

  • 00850049194235 ()


  • Air-conduction hearing aid, receiver-in-canal
NoviOne RIC OTC Hearing Aids, Pair - Beige
Novidan, Inc.
99-0001-14
In Commercial Distribution

  • 00850049194228 ()


  • Air-conduction hearing aid, receiver-in-canal
Pro OTC RIC Hearing Aids, Pair - Charcoal
Novidan, Inc.
99-0007-06
In Commercial Distribution

  • 00850049194211 ()


  • Air-conduction hearing aid, receiver-in-canal
Pro OTC RIC Hearing Aids, Pair - Slate
Novidan, Inc.
99-0007-05
In Commercial Distribution

  • 00850049194204 ()


  • Air-conduction hearing aid, receiver-in-canal
Pro OTC RIC Hearing Aids, Pair - Beige
Novidan, Inc.
99-0007-04
In Commercial Distribution

  • 00850049194198 ()


  • Air-conduction hearing aid, receiver-in-canal
Mach I Pro OTC Hearing Aids - Charcoal
Novidan, Inc.
99-0006-08
In Commercial Distribution

  • 00850049194181 ()


  • Air-conduction hearing aid, receiver-in-canal
Lexie Lumen OTC Hearing Aids - Beige Online
HEARX GROUP (PTY) LTD
Lexie Lumen Duo Beige
In Commercial Distribution

  • 00850022464157 ()
LLO00003BE

  • Air-conduction hearing aid, receiver-in-canal
Lexie Lumen OTC Hearing Aids - Gray Online
HEARX GROUP (PTY) LTD
Lexie Lumen Duo Gray
In Commercial Distribution

  • 00850022464065 ()
LLO00001GR

  • Air-conduction hearing aid, receiver-in-canal
It is hair grow system for OTC
Xuzhou Kernel Medical Equipment Co., Ltd.
KN-8000B
In Commercial Distribution

  • 06928798600353 ()


  • Hair growth laser device
Intense pulse light OTC hair removal device
SPECTRUM BRANDS, INC.
IPL7000
In Commercial Distribution

  • 10074590552567 ()
  • 00074590552560 ()


  • Intense pulsed light skin surface treatment system
Intense Pulse Light OTC hair removal device
SPECTRUM BRANDS, INC.
IPL2500USA
In Commercial Distribution

  • 10074590546030 ()
  • 00074590546033 ()


  • Intense pulsed light skin surface treatment system
Intense Pulse Light OTC hair removal device
SPECTRUM BRANDS, INC.
IPL7510
In Commercial Distribution

  • 00074590544503 ()
  • 10074590544500 ()


  • Intense pulsed light skin surface treatment system
Intense Pulsed Light OTC hair removal device
SPECTRUM BRANDS, INC.
IPL6500QFB
In Commercial Distribution

  • 10074590544265 ()
  • 00074590544268 ()


  • Intense pulsed light skin surface treatment system
Intense Pulsed Light OTC hair removal device
SPECTRUM BRANDS, INC.
IPL6800R
In Commercial Distribution

  • 10074590543138 ()
  • 00074590543131 ()


  • Intense pulsed light skin surface treatment system
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