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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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
OTC hearing aids, behind-the-ear design, one pair
Voxx Accessories Corp.
RSH052BK
In Commercial Distribution

  • 00044476153280 ()


  • Air-conduction hearing aid, behind-the-ear
OTC hearing aids, behind-the-ear design, one pair
Voxx Accessories Corp.
RSH052GY
In Commercial Distribution

  • 00044476153273 ()


  • Air-conduction hearing aid, behind-the-ear
OTC hearing aids, behind-the-ear design, one pair
Voxx Accessories Corp.
RSH052BG
In Commercial Distribution

  • 00044476153266 ()


  • Air-conduction hearing aid, behind-the-ear
OTC hearing aids, with battery display case
Voxx Accessories Corp.
RSH20WH
In Commercial Distribution

  • 00044476153198 ()


  • Air-conduction hearing aid, in-the-ear
OTC hearing aids, with battery display case
Voxx Accessories Corp.
RSH20GYW
In Commercial Distribution

  • 00044476153181 ()


  • Air-conduction hearing aid, in-the-ear
OTC hearing aids, with battery display case
Voxx Accessories Corp.
RSH20BGW
In Commercial Distribution

  • 00044476153174 ()


  • Air-conduction hearing aid, in-the-ear
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
Intense Pulsed Light OTC hair removal device
SPECTRUM BRANDS, INC.
IPL6000Q-R
In Commercial Distribution

  • 10074590542971 ()
  • 00074590542974 ()


  • Intense pulsed light skin surface treatment system
Intense Pulsed Light OTC Hair Removal Device
SPECTRUM BRANDS, INC.
IPL6800USA
In Commercial Distribution

  • 10074590540342 ()
  • 00074590540345 ()


  • Intense pulsed light skin surface treatment system
Intense Pulse Light OTC hair removal device
SPECTRUM BRANDS, INC.
IPL2000USA
In Commercial Distribution

  • 10074590535478 ()
  • 00074590535471 ()


  • Intense pulsed light skin surface treatment system
Intense Pulsed Light OTC hair removal device
SPECTRUM BRANDS, INC.
IPL6000Q
In Commercial Distribution

  • 10074590530404 ()
  • 00074590530407 ()


  • Intense pulsed light skin surface treatment system
Intense Pulsed Light OTC hair removal device
SPECTRUM BRANDS, INC.
IPL6000USA
In Commercial Distribution

  • 10074590512172 ()
  • 00074590512175 ()


  • Intense pulsed light skin surface treatment system
QuikClot Bleeding Control Kit, Stanford, OTC, CAT
Z-MEDICA, LLC
0613
In Commercial Distribution

  • 00841495106132 ()
0613

  • Non-organic haemostatic agent
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
Procellera Single Layer OTC, 4"x 4"
Vomaris Wound Care, Inc.
4" x 4"
In Commercial Distribution

  • 00810198030389 ()
VSC-0404

  • Bioelectric wound dressing
XRAY OTC 80KW 400KHU AUTOTILT CF OSHPD
CARESTREAM HEALTH, INC.
DRX-Compass X-ray System
In Commercial Distribution

  • 60889978624768 ()
8624769

  • Stationary basic diagnostic x-ray system, digital
Mepilex Border Flex Lite 10x10cm, OTC US
Mölnlycke Health Care AB
281333
In Commercial Distribution

  • 07333350551346 ()
  • 07333350197629 ()
  • 07333350874711 ()

  • 10cm x 10cm


  • Wound-nonadherent dressing, absorbent, non-antimicrobial
Mepilex Border Flex Lite 5x12,5cm, OTC US
Mölnlycke Health Care AB
281133
In Commercial Distribution

  • 07333350515904 ()
  • 07333350661663 ()
  • 07333350125578 ()

  • 5cm x 12,5cm


  • Wound-nonadherent dressing, absorbent, non-antimicrobial
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
Engage Android OTC Rechargeable Grey Replacement Right
HEARING LAB TECHNOLOGY, LLC
7495
In Commercial Distribution

  • 00810068831870 ()
10098-R REPLACE

  • Air-conduction hearing aid, receiver-in-the-ear
Engage Android OTC Rechargeable Grey Replacement Left
HEARING LAB TECHNOLOGY, LLC
7495
In Commercial Distribution

  • 00810068831863 ()
10098-L REPLACE

  • Air-conduction hearing aid, receiver-in-the-ear
Engage MFI OTC Rechargeable Grey Replacement Right
HEARING LAB TECHNOLOGY, LLC
7595
In Commercial Distribution

  • 00810068831856 ()
10097-R REPLACE

  • Air-conduction hearing aid, receiver-in-the-ear
Engage MFI OTC Rechargeable Grey Replacement Left
HEARING LAB TECHNOLOGY, LLC
7595
In Commercial Distribution

  • 00810068831849 ()
10097-L REPLACE

  • Air-conduction hearing aid, receiver-in-the-ear
Engage Android OTC Rechargeable Black Replacement Right
HEARING LAB TECHNOLOGY, LLC
7495
In Commercial Distribution

  • 00810068831832 ()
10096-R REPLACE

  • Air-conduction hearing aid, receiver-in-the-ear
Engage Android OTC Rechargeable Black Replacement Left
HEARING LAB TECHNOLOGY, LLC
7495
In Commercial Distribution

  • 00810068831825 ()
10096-L REPLACE

  • Air-conduction hearing aid, receiver-in-the-ear
Engage MFI OTC Rechargeable Black Replacement Right
HEARING LAB TECHNOLOGY, LLC
7595
In Commercial Distribution

  • 00810068831818 ()
10095-R REPLACE

  • Air-conduction hearing aid, receiver-in-the-ear
Engage MFI OTC Rechargeable Black Replacement Left
HEARING LAB TECHNOLOGY, LLC
7595
In Commercial Distribution

  • 00810068831801 ()
10095-L REPLACE

  • Air-conduction hearing aid, receiver-in-the-ear
Engage Android Rechargeable OTC Beige Replacement Right
HEARING LAB TECHNOLOGY, LLC
7495
In Commercial Distribution

  • 00810068831795 ()
10080-R REPLACE

  • Air-conduction hearing aid, receiver-in-the-ear
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