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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Elevate Tongue Cleaner Pink
ELEVATE ORAL CARE, LLC
655PINK00
Not in Commercial Distribution

  • 00858290006031 ()


  • Tongue scraper, single-use
No Description
Vista Dental
309001
In Commercial Distribution

  • 10818207022964 ()


  • Tongue scraper, single-use
The Dale Scrape-n-Suction Tongue Cleaner is a plastic device with a hollow core that allows it to be attached to a vacuum source to remove biofilm from the tongue.
Dale Medical Products, Inc.
220
In Commercial Distribution

  • 00817612021015 ()
  • 00817612021008 ()
220

  • Tongue scraper, single-use
No Description
Shenzhen Lutejiacheng Supply Chain Management Co., Ltd.
MCTB01_Orange_2pc
In Commercial Distribution

  • 06975983272130 ()


  • Tongue scraper, single-use
External Penile Rigidity Device that contains kit bag, manual vacuum pump, battery vacuum pump,constriction rings, cylinder, lubricant, comfort inserts, loading cone, 9 volt battery.
AUGUSTA MEDICAL SYSTEMS, L.L.C.
External Penile Rigidity Device
In Commercial Distribution

  • 00852598007127 ()


  • Penile vacuum device
External Penile Rigidity Device that contains kit bag, battery vacuum pump, tension systems, cylinder, lubricant, comfort inserts, loading cone, 9 volt battery.
AUGUSTA MEDICAL SYSTEMS, L.L.C.
External Penile Rigidity Device
In Commercial Distribution

  • 00852598007110 ()


  • Penile vacuum device
Battery Vacuum Pump
AUGUSTA MEDICAL SYSTEMS, L.L.C.
Battery Vacuum Pump
In Commercial Distribution

  • 00852598007059 ()


  • Penile vacuum device
Vashe® Wound Solution OTC is a wound cleansing solution that is intended for cleansing, irrigating, debriding dermal wounds in addition to moistening and lubricating absorbent wound dressings. Vashe® Wound Solution OTC is intended for OTC use for management of minor skin abrasions, minor lacerations, minor irritations, minor cuts, and intact skin.
URGO MEDICAL NORTH AMERICA, LLC
00405
In Commercial Distribution

  • 10190769004054 ()
  • 00190769004057 ()

  • Total Volume: 250 Milliliter
00405

  • Antimicrobial wound irrigation solution
The Stork® OTC packages include: Instructions for Use (IFU), one Conceptacle® and one plastic applicator. Once the couple has decided to attempt to become pregnant, the Stork® OTC Conception System Instruction for Use recommends using the device during female’s most fertile days in a given month. During sexual intercourse, semen will be collected using the Conceptacle®, a cervical cap that is pre-inserted into a condom-like sheath. The male removes the Conceptacle® from the penis by rolling it down and separating it from the penis. After removal, the rim of the cervical cap is lightly pinched so that the Condom-like Sheath can be separated. (The Cervical Cap and Condom-like Sheath are separated in two separate parts). The semen is contained in the cervical cap and its reservoir. The second component, the Applicator, is used for ease of transition of the Cervical Cap to the cervix. The applicator seals the Cervical Cap and contains the semen for transition through the vaginal tract, assisting the female in guiding the cap to the cervix and releasing the semen and the cap in front of the cervix. When the cervical cap is loaded onto the applicator (while it is still outside of the body), the Retainer locks onto the Cervical Cap and is delivered with the Cervical Cap intra-vaginally. The Retainer also has a removal cord that is attached for withdrawal. The Cervical Cap and Retainer then remain in place for up to 6 hours.
STORK IB2C, INC., THE
USOTC
In Commercial Distribution

  • 00810396020007 ()


  • Conceptive cervical cap, single-use
OTC Hearing Aid - Good Voice Everyday
OK BIOTECH CO., LTD.
GV-SA03.60
In Commercial Distribution

  • 00193169001602 ()
  • 00193169003606 ()
30-81-0300-0103

  • Air-conduction hearing aid, in-the-ear
Pulse Ox OTC
VERIDIAN HEALTHCARE LLC
21602
In Commercial Distribution

  • 00682891216021 ()


  • Pulse oximeter
Pulse Ox OTC
VERIDIAN HEALTHCARE LLC
21601
In Commercial Distribution

  • 00682891216014 ()


  • Pulse oximeter
Pulse Ox OTC
VERIDIAN HEALTHCARE LLC
21600
In Commercial Distribution

  • 00682891216007 ()


  • Pulse oximeter
OTC Hearing Aid
Audicon Corporation
Nexus
In Commercial Distribution

  • 10850065321018 ()
  • 00850065321011 ()
  • 20850065321015 ()


  • Air-conduction hearing aid, behind-the-ear
OTC Hearing Aid
Audicon Corporation
Core one
In Commercial Distribution

  • 20860010331099 ()
  • 00860010331095 ()
  • 10860010331092 ()
  • 30860010331096 ()


  • Air-conduction hearing aid, in-the-ear
OTC Hearing Aid
Audicon Corporation
Beacon
In Commercial Distribution

  • 10860010331030 ()
  • 00860010331033 ()
  • 20860010331037 ()
  • 30860010331034 ()


  • Air-conduction hearing aid, behind-the-ear
1T, FDA OTC
Hangzhou AllTest Biotech Co., Ltd.
1
In Commercial Distribution

  • 06936983167116 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
1T, FDA OTC
Hangzhou AllTest Biotech Co., Ltd.
1
In Commercial Distribution

  • 06936983155748 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
1T, FDA OTC
Hangzhou AllTest Biotech Co., Ltd.
1
In Commercial Distribution

  • 06936983155144 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
Enrich BTE OTC
HEARING LAB TECHNOLOGY, LLC
Enrich
In Commercial Distribution

  • 00810068831436 ()
10081

  • Air-conduction hearing aid, behind-the-ear
CRYOTHERAPY H 2X88ML W/30 ARW&50 RND BDS
MEDLINE INDUSTRIES, INC.
OTCM170375
In Commercial Distribution

  • 10193489084818 ()
OTCM170375

  • Wart-removal cryogenic kit
CRYOTHERAPY H 88ML REPLACEMENT CANISTER
MEDLINE INDUSTRIES, INC.
OTCM170100
In Commercial Distribution

  • 10193489084795 ()
OTCM170100

  • Wart-removal cryogenic kit
CRYOTHERAPY V 236ML KIT 6 CONES+60 BUDS
MEDLINE INDUSTRIES, INC.
OTCM1501
In Commercial Distribution

  • 10193489084788 ()
OTCM1501

  • Wart-removal cryogenic kit
CRYOTHERAPY V 236ML REPLACEMENT CANISTER
MEDLINE INDUSTRIES, INC.
OTCM1500
In Commercial Distribution

  • 10193489084771 ()
OTCM1500

  • Wart-removal cryogenic kit
CRYOTHERAPY V 175ML KIT 6 CONES+60 BUDS
MEDLINE INDUSTRIES, INC.
OTCM1101
In Commercial Distribution

  • 10193489084764 ()
OTCM1101

  • Wart-removal cryogenic kit
LEG GARMENT, DAYSPRING, LONG, RIGHT
Koya Medical, Inc.
F-0040-08
In Commercial Distribution

  • 00850012532798 ()


  • Wearable sequential venous compression system
LEG GARMENT, DAYSPRING, LONG, LEFT
Koya Medical, Inc.
F-0040-07
In Commercial Distribution

  • 00850012532781 ()


  • Wearable sequential venous compression system
LEG GARMENT, DAYSPRING, MEDIUM, RIGHT
Koya Medical, Inc.
F-0040-06
In Commercial Distribution

  • 00850012532774 ()


  • Wearable sequential venous compression system
LEG GARMENT, DAYSPRING, MEDIUM, LEFT
Koya Medical, Inc.
F-0040-05
In Commercial Distribution

  • 00850012532767 ()


  • Wearable sequential venous compression system
LEG GARMENT, DAYSPRING, SHORT, RIGHT
Koya Medical, Inc.
F-0040-04
In Commercial Distribution

  • 00850012532750 ()


  • Wearable sequential venous compression system
LEG GARMENT, DAYSPRING, SHORT, LEFT
Koya Medical, Inc.
F-0040-03
In Commercial Distribution

  • 00850012532743 ()


  • Wearable sequential venous compression system
LOWER LEG GARMENT
Koya Medical, Inc.
F-0050-02
Not in Commercial Distribution

  • 00850012532736 ()


  • Wearable sequential venous compression system
ARM GARMENT, LONG
Koya Medical, Inc.
F-0010-09
Not in Commercial Distribution

  • 00850012532729 ()


  • Wearable sequential venous compression system
ARM GARMENT, MED
Koya Medical, Inc.
F-0010-08
Not in Commercial Distribution

  • 00850012532712 ()


  • Wearable sequential venous compression system
ARM GARMENT, SHORT
Koya Medical, Inc.
F-0010-07
Not in Commercial Distribution

  • 00850012532705 ()


  • Wearable sequential venous compression system
ARM GARMENT, DAYSPRING, LONG
Koya Medical, Inc.
F-0010-06
In Commercial Distribution

  • 00850012532699 ()


  • Wearable sequential venous compression system
ARM GARMENT, DAYSPRING, MEDIUM
Koya Medical, Inc.
F-0010-05
In Commercial Distribution

  • 00850012532682 ()


  • Wearable sequential venous compression system
ARM GARMENT, DAYSPRING, SHORT
Koya Medical, Inc.
F-0010-04
In Commercial Distribution

  • 00850012532675 ()


  • Wearable sequential venous compression system
CONTROLLER, DAYSPRING, LITE
Koya Medical, Inc.
F-0085-01
In Commercial Distribution

  • 00850012532651 ()
F-0085-01

  • Wearable sequential venous compression system
LOWER LEG GARMENT, DAYSPRING
Koya Medical, Inc.
F-0050-01
In Commercial Distribution

  • 00850012532644 ()
F-0050-01

  • Wearable sequential venous compression system
LEG GARMENT, DAYSPRING, LONG
Koya Medical, Inc.
F-0040-02
In Commercial Distribution

  • 00850012532637 ()
F-0040-02

  • Wearable sequential venous compression system
LEG GARMENT, DAYSPRING, STANDARD
Koya Medical, Inc.
F-0040-01
In Commercial Distribution

  • 00850012532620 ()
F-0040-01

  • Wearable sequential venous compression system
Dayspring Mobile Application
Koya Medical, Inc.
SW 005
In Commercial Distribution

  • 00850012532613 ()
SW 005

  • Wearable sequential venous compression system
Arm Liner, X-Large
Koya Medical, Inc.
F-0020-04
In Commercial Distribution

  • 00850012532606 ()
F-0020-04

  • Wearable sequential venous compression system
KIT, DAYSPRING, F-0100-23
Koya Medical, Inc.
F-0100-23
In Commercial Distribution

  • 00850012532590 ()
F-0100-23

  • Wearable sequential venous compression system
Dayspring Wearable Device - Long Arm Garment, X-Large Arm Liner, X-Large Gauntlet, Dayspring Controller, and Dayspring Charger
Koya Medical, Inc.
F-0100-47
In Commercial Distribution

  • 00850012532583 ()
F-0100-47

  • Wearable sequential venous compression system
KIT, DAYSPRING, F-0100-47
Koya Medical, Inc.
F-0100-47
In Commercial Distribution

  • 00850012532576 ()
F-0100-47

  • Wearable sequential venous compression system
Dayspring Wearable Device - Long Arm Garment, Medium Arm Liner, X-Large Gauntlet, Dayspring Controller, and Dayspring Charger
Koya Medical, Inc.
F-0100-46
In Commercial Distribution

  • 00850012532569 ()
F-0100-46

  • Wearable sequential venous compression system
Dayspring Wearable Device - Long Arm Garment, Small Arm Liner, X-Large Gauntlet, Dayspring Controller, and Dayspring Charger
Koya Medical, Inc.
F-0100-45
In Commercial Distribution

  • 00850012532552 ()
F-0100-45

  • Wearable sequential venous compression system
Dayspring Wearable Device - Long Arm Garment, X-Large Arm Liner, Large Gauntlet, Dayspring Controller, and Dayspring Charger
Koya Medical, Inc.
F-0100-44
In Commercial Distribution

  • 00850012532545 ()
F-0100-44

  • Wearable sequential venous compression system
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