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

  • 00023513000039 ()
  • 00036800468450 ()


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

  • 00023513487441 ()


  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical
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
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
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
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
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