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 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
Engage Android Rechargeable OTC Beige Replacement Left
HEARING LAB TECHNOLOGY, LLC
7495
In Commercial Distribution

  • 00810068831788 ()
10080-L REPLACE

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

  • 00810068831771 ()
10079-R REPLACE

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

  • 00810068831764 ()
10079-L REPLACE

  • Air-conduction hearing aid, receiver-in-the-ear
Powered wheelchair (mobility robot), Model: M4U; OTC
XSTO CO., LTD.
M4U
In Commercial Distribution

  • 06975052650111 ()


  • Electric-motor-driven wheelchair, occupant-controlled
Powered wheelchair (mobility robot), Model: M4; OTC
XSTO CO., LTD.
M4
In Commercial Distribution

  • 06975052650098 ()


  • Electric-motor-driven wheelchair, occupant-controlled
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
(Authentic Accessory) Bluetooth Earphones for OKB OTC Hearing Aid GV-SA03.60
OK BIOTECH CO., LTD.
HT001
In Commercial Distribution

  • 00193169003507 ()
30-81-0300-0303

  • Air-conduction hearing aid, in-the-ear
No Description
Sonoma Pharmaceuticals, Inc.
86012
In Commercial Distribution

  • 20850015491676 ()
  • 00850015491672 ()

  • Total Volume: 118 Milliliter
86012

  • Non-antimicrobial wound irrigation solution, multiple solute
No Description
Sonoma Pharmaceuticals, Inc.
86005
In Commercial Distribution

  • 20850015491492 ()
  • 00850015491498 ()

  • Total Volume: 59 Milliliter
86005

  • Non-antimicrobial wound irrigation solution, multiple solute
Topical burn and wound dressing, hydrogel barrier antimicrobial with silver and lidocaine, OTC indications, 1oz spray, pack of 15
Kericure Inc.
5031810C15
In Commercial Distribution

  • 00858071004195 ()
  • 00858071004904 ()


  • Wound hydrogel dressing, antimicrobial
Hearing Aid, Air-Conduction with Wireless Technology, OTC, Mach 1 Pro W OTC Hearing Aids - Charcoal, pair, 312 battery
Novidan, Inc.
99-0014-03
In Commercial Distribution

  • 00850049194099 ()


  • Air-conduction hearing aid, receiver-in-canal
Hearing Aid, Air-Conduction with Wireless Technology, OTC, Mach 1 Pro W OTC Hearing Aids - Slate, pair, 312 battery
Novidan, Inc.
99-0014-02
In Commercial Distribution

  • 00850049194082 ()


  • Air-conduction hearing aid, receiver-in-canal
Hearing Aid, Air-Conduction with Wireless Technology, OTC, Mach I Pro W OTC Hearing Aids - Beige, pair, 312 battery
Novidan, Inc.
99-0014-01
In Commercial Distribution

  • 00850049194075 ()


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

  • 06928798600360 ()


  • Hair growth laser device
It is hair growing system for OTC use
Xuzhou Kernel Medical Equipment Co., Ltd.
KN-8000E
In Commercial Distribution

  • 06928798600346 ()


  • Hair growth laser device
It is hair growing system for OTC use
Xuzhou Kernel Medical Equipment Co., Ltd.
KN-8000D
In Commercial Distribution

  • 06928798600339 ()


  • Hair growth laser device
Mach II Pro OTC Hearing Aids - Graphite Pair
Novidan, Inc.
99-0016-06
In Commercial Distribution

  • 00850049194426 ()


  • Air-conduction hearing aid, receiver-in-canal
Mach II Pro OTC Hearing Aids - Beige Pair
Novidan, Inc.
99-0016-05
In Commercial Distribution

  • 00850049194419 ()


  • Air-conduction hearing aid, receiver-in-canal
Mach II Pro OTC Hearing Aids - Glacier Pair
Novidan, Inc.
99-0016-04
In Commercial Distribution

  • 00850049194402 ()


  • Air-conduction hearing aid, receiver-in-canal
NoviOne RIC Rechargeable OTC Hearing Aids - Graphite Pair
Novidan, Inc.
99-0010-06
In Commercial Distribution

  • 00850049194396 ()


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