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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Mepilex Border Flex Lite 4x5cm, OTC US
Mölnlycke Health Care AB
281033
In Commercial Distribution

  • 07333350399870 ()
  • 07333350372361 ()
  • 07333350578718 ()

  • 4cm x 5cm


  • Wound-nonadherent dressing, absorbent, non-antimicrobial
Mepilex Border Flex Lite 7,5x7,5cm, OTC US
Mölnlycke Health Care AB
281233
In Commercial Distribution

  • 07333350389048 ()
  • 07333350053819 ()
  • 07333350408848 ()

  • 7,5cm x 7,5cm


  • Wound-nonadherent dressing, absorbent, non-antimicrobial
Procellera Single Layer OTC, 4"x 4"
Vomaris Wound Care, Inc.
4" x 4"
In Commercial Distribution

  • 00810198030389 ()
VSC-0404

  • Bioelectric wound dressing
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
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
Tala Charger for Tala OTC Hearing Aid
ETYMOTIC RESEARCH, INC.
TALA CHARGER
In Commercial Distribution

  • 00846430005860 ()


  • Air-conduction hearing aid, in-the-ear
QuikClot Bleeding Control Kit, Stanford, OTC, CAT
Z-MEDICA, LLC
0613
In Commercial Distribution

  • 00841495106132 ()
0613

  • Non-organic haemostatic agent
It is hair grow system for OTC
Xuzhou Kernel Medical Equipment Co., Ltd.
KN-8000B
In Commercial Distribution

  • 06928798600353 ()


  • Hair growth laser device
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,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
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
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
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
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
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