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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Mach II Pro Wireless OTC Hearing Aids - Graphite Pair
Novidan, Inc.
99-0016-03
In Commercial Distribution

  • 00850049194334 ()


  • Air-conduction hearing aid, receiver-in-canal
Mach II Pro Wireless OTC Hearing Aids - Beige Pair
Novidan, Inc.
99-0016-02
In Commercial Distribution

  • 00850049194327 ()


  • Air-conduction hearing aid, receiver-in-canal
Mach II Pro Wireless OTC Hearing Aids - Glacier Pair
Novidan, Inc.
99-0016-01
In Commercial Distribution

  • 00850049194310 ()


  • Air-conduction hearing aid, receiver-in-canal
NoviOne RIC Wireless Rechargeable OTC Hearing Aids - Graphite Pair
Novidan, Inc.
99-0010-03
In Commercial Distribution

  • 00850049194303 ()


  • Air-conduction hearing aid, receiver-in-canal
NoviOne RIC Wireless Rechargeable OTC Hearing Aids - Beige Pair
Novidan, Inc.
99-0010-02
In Commercial Distribution

  • 00850049194297 ()


  • Air-conduction hearing aid, receiver-in-canal
Mach I Pro OTC RIC Hearing Aids, Pair - Slate
Novidan, Inc.
99-0006-07
In Commercial Distribution

  • 00850049194174 ()


  • Air-conduction hearing aid, receiver-in-canal
Mach I Pro OTC RIC Hearing Aids, Pair - Beige
Novidan, Inc.
99-0006-06
In Commercial Distribution

  • 00850049194167 ()


  • Air-conduction hearing aid, receiver-in-canal
Go Hearing, Go Ultra BTE OTC hearing aid, Grey.
HEARX GROUP (PTY) LTD
Go Ultra
In Commercial Distribution

  • 00850022464959 ()


  • Air-conduction hearing aid, behind-the-ear
Intense Pulse Light OTC hair removal device spare part
SPECTRUM BRANDS, INC.
SP7SB
In Commercial Distribution

  • 10074590547891 ()
  • 00074590547894 ()


  • Intense pulsed light skin surface treatment system
Intense Pulse Light OTC hair removal device spare part
SPECTRUM BRANDS, INC.
SP2000HR
In Commercial Distribution

  • 10074590542926 ()
  • 00074590542929 ()


  • Intense pulsed light skin surface treatment system
Over-The-Counter (OTC) Transcutaneous Electrical Nerve Stimulator (TENS) - Back & Hip
CHATTEM, INC.
SmartRelief 1.0 - Back/Hip Kit
In Commercial Distribution

  • 00041167080450 ()


  • Transcutaneous electrical stimulation electrode, single-use
REPLACEMENT ELECTRODE KIT, OTC INTENSITY AT HOME ELECTRODES, 8CT
COMPASS HEALTH BRANDS CORP.
E201-6R
In Commercial Distribution

  • 00092237619605 ()


  • Transcutaneous electrical stimulation electrode, single-use
HORMONElife™ Ultra Accurate FSH Test Strip OTC 6PK
WONDFO USA CO., LTD.
W52-S-SQ-6BX
In Commercial Distribution

  • 10816862027249 ()
  • 00816862027242 ()
  • 00816862027235 ()


  • Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing
One 3.38 FL OZ (100 mL) bottle with one lice comb.
MENTHOLATUM COMPANY, THE
1123
In Commercial Distribution

  • 00310742011234 ()


  • Lice treatment solution, synthetic
  • Lice comb, manual
Hydrocolloid Blister Cushions, assorted cushions, 0.66 in. x 2.32 in. (17mm x 59mm); 1.33 in. x 2.12in. (34mm x 54mm); 1.65 IN x 2.67 IN (42 mm x 68 mm)
Ahold U.S.A., Inc.
041520104854
In Commercial Distribution

  • 10041520104851 ()
  • 00041520104854 ()
  • 60041520104856 ()


  • Exudate-absorbent dressing, hydrophilic-gel, non-sterile
  • Corn/callus dressing, single-use
The Mobility+ Enteral Feeding System (“Mobility+ System”) is a portable, lightweight, non-electronic, disposable enteral feeding system intended to deliver commercially available liquid nutrition formula to a patient, using a standard extension set (or feeding tube) with an ENFit® connector, in the clinical or home care settings.
ROCKFIELD MEDICAL DEVICES LIMITED
MOB2-0440
In Commercial Distribution

  • 05391537090165 ()
  • 05391537090127 ()
  • 05391537090202 ()
  • 05391537090240 ()
  • 05391537090288 ()
  • 05391537090325 ()

  • Length: 440 Millimeter
MOB2-0440-30, MOB2-0440-03, MOB2-0440-03-09, MOB2-0440-10, MOB2-0440-10-03

  • Enteral feeding noninvasive-component set
1 - TMT-Tourniquet 1 - Celox RAPID B-Con 1 - Positional Airway Card 2 - Sentinel Chest Seal 1 - Emergency Bandage 1 - Blizzard IFAK Blanket 2 - Exam Gloves 1 - Quick Reference Guide
Safeguard US Operating, LLC
1
In Commercial Distribution

  • M689SDRVSIPOTC010 ()
SDR-VSIP-OTC

  • First aid kit, non-medicated, single-use
Topical wound dressing, hydrogel barrier antimicrobial with lidocaine, OTC indications, 0.5oz spray, 24 pack
Kericure Inc.
5031805C24
In Commercial Distribution

  • 00858071004287 ()
  • 00858071004898 ()


  • Wound hydrogel dressing, antimicrobial
No Description
POS-T-VAC INC
Erecaid Classic OTC System
In Commercial Distribution

  • 00857312008343 ()
91114

  • Penile vacuum device
No Description
Tomore Healthcare (Dongguan) Co.,Ltd.
OTC, Behind-THE-EAR Hearing Aids
In Commercial Distribution

  • 06977275990678 ()


  • Air-conduction hearing aid acoustic tube
No Description
Tomore Healthcare (Dongguan) Co.,Ltd.
OTC, Behind-THE-EAR Hearing Aid
In Commercial Distribution

  • 06977275990036 ()


  • Air-conduction hearing aid acoustic tube
WoundClot is a soluble dressing, based on cellulosic structure. In contact with liquids it forms absorbent gel which adheres to the wound surface to control bleeding. WoundClot is intended to be used as a topical dressing for minor skin surface bleeding wounds such as minor cuts and minor abrasions.
CORE SCIENTIFIC CREATIONS LTD
3"X23.6" OTC FDA
In Commercial Distribution

  • 17290016339410 ()
  • 07290016339413 ()
101586901

  • Plant polysaccharide haemostatic agent, bioabsorbable
WoundClot is a soluble dressing, based on cellulosic structure. In contact with liquids it forms absorbent gel which adheres to the wound surface to control bleeding. WoundClot is intended to be used as a topical dressing for minor skin surface bleeding wounds such as minor cuts and minor abrasions.
CORE SCIENTIFIC CREATIONS LTD
3"X8" OTC FDA
In Commercial Distribution

  • 17290016339403 ()
  • 07290016339406 ()
101582901

  • Plant polysaccharide haemostatic agent, bioabsorbable
WoundClot is a soluble dressing, based on cellulosic structure. In contact with liquids it forms absorbent gel which adheres to the wound surface to control bleeding. WoundClot is intended to be used as a topical dressing for minor skin surface bleeding wounds such as minor cuts and minor abrasions.
CORE SCIENTIFIC CREATIONS LTD
2"X2" OTC FDA
In Commercial Distribution

  • 17290016339397 ()
  • 07290016339390 ()
101555901

  • Plant polysaccharide haemostatic agent, bioabsorbable
WoundClot is a soluble dressing, based on cellulosic structure. In contact with liquids it forms absorbent gel which adheres to the wound surface to control bleeding. WoundClot is intended to be used as a topical dressing for minor skin surface bleeding wounds such as minor cuts and minor abrasions.
CORE SCIENTIFIC CREATIONS LTD
8"X12" OTC FDA
In Commercial Distribution

  • 17290016339380 ()
  • 07290016339383 ()
101523901

  • Plant polysaccharide haemostatic agent, bioabsorbable
WoundClot is a soluble dressing, based on cellulosic structure. In contact with liquids it forms absorbent gel which adheres to the wound surface to control bleeding. WoundClot is intended to be used as a topical dressing for minor skin surface bleeding wounds such as minor cuts and minor abrasions.
CORE SCIENTIFIC CREATIONS LTD
4"X4" OTC FDA
In Commercial Distribution

  • 07290016339376 ()
  • 17290016339373 ()
101511901

  • Plant polysaccharide haemostatic agent, bioabsorbable
No Description
Huizhou Jinghao Medical Technology Co., Ltd
OTC CIC DIGITAL Recharge
In Commercial Distribution

  • 16971094537417 ()
  • 06971094537410 ()


  • Air-conduction hearing aid, in-the-ear
No Description
Huizhou Jinghao Medical Technology Co., Ltd
OTC X2R DCi B
In Commercial Distribution

  • 06971094537397 ()
  • 16971094537394 ()


  • Air-conduction hearing aid, receiver-in-the-ear
LEFT-LARGE/991009-SWH; replacement RIC for Sontro Self-Fitting OTC Hearing Aids
Soundwave Hearing, LLC
991009-SWH
In Commercial Distribution

  • 00850016231277 ()


  • Air-conduction hearing aid acoustic tube
LEFT-MEDIUM/991008-SWH; replacement RIC for Sontro Self-Fitting OTC Hearing Aids
Soundwave Hearing, LLC
991008-SWH
In Commercial Distribution

  • 00850016231260 ()


  • Air-conduction hearing aid acoustic tube
LEFT-SMALL/991007-SWH; replacement RIC for Sontro Self-Fitting OTC Hearing Aids
Soundwave Hearing, LLC
991007-SWH
In Commercial Distribution

  • 00850016231253 ()


  • Air-conduction hearing aid acoustic tube
RIGHT-LARGE/991006-SWH; replacement RIC for Sontro Self-Fitting OTC Hearing Aids
Soundwave Hearing, LLC
991006-SWH
In Commercial Distribution

  • 00850016231246 ()


  • Air-conduction hearing aid acoustic tube
RIGHT-MEDIUM/991005-SWH; replacement RIC for Sontro Self-Fitting OTC Hearing Aids
Soundwave Hearing, LLC
991005-SWH
In Commercial Distribution

  • 00850016231239 ()


  • Air-conduction hearing aid acoustic tube
RIGHT-SMALL/991004-SWH; replacement RIC for Sontro Self-Fitting OTC Hearing Aids
Soundwave Hearing, LLC
991004-SWH
In Commercial Distribution

  • 00850016231222 ()


  • Air-conduction hearing aid acoustic tube
Over-The-Counter (OTC) Transcutaneous Electrical Nerve Stimulator (TENS) - Knee and Shoulder
CHATTEM, INC.
SmartRelief 1.0 - Knee/Shoulder Kit
In Commercial Distribution

  • 00041167080474 ()


  • Transcutaneous electrical stimulation electrode, single-use
Self-Fit OTC Hearing Aid Pair, wireless, rechargeable, cool gray color
Novidan, Inc.
EH-Z2000-H
In Commercial Distribution

  • 00046838505065 ()
  • 10046838505062 ()


  • Air-conduction hearing aid, receiver-in-canal
1-Cassette; FTY Fentanyl 1 ng/ml OTC; 5 Tests/Kitbox
WONDFO USA CO., LTD.
WDFT-201-OTC1-5BX
In Commercial Distribution

  • 10816862024996 ()
  • 00816862024999 ()
  • 00816862024982 ()


  • Fentanyl IVD, kit, rapid ICT, clinical
1-Cassette; FTY Fentanyl 1 ng/ml OTC; 10 Tests/Kitbox
WONDFO USA CO., LTD.
WDFT-201-OTC1-10BX
In Commercial Distribution

  • 10816862024972 ()
  • 00816862024975 ()
  • 00816862024968 ()


  • Fentanyl IVD, kit, rapid ICT, clinical
1-Cassette; FTY Fentanyl 1 ng/ml OTC; 25 Tests/Kitbox
WONDFO USA CO., LTD.
WDFT-201-OTC1-25BX
In Commercial Distribution

  • 10816862024958 ()
  • 00816862024951 ()
  • 00816862024944 ()


  • Fentanyl IVD, kit, rapid ICT, clinical
1-Cassette; FTY Fentanyl 1 ng/ml OTC; 1 Test/Kitbox
WONDFO USA CO., LTD.
WDFT-201-OTC1-1BX
In Commercial Distribution

  • 10816862025870 ()
  • 00816862025873 ()


  • Fentanyl IVD, kit, rapid ICT, clinical
Water flosser and sonic toothbrush, white
WATER PIK, INC.
CC-04CD010-1
In Commercial Distribution

  • 00073950330046 ()
CC-04CD010-1

  • Oral lavage system
  • Basic electric toothbrush
Rechargeable water flosser and sonic toothbrush, white
WATER PIK, INC.
STW-03W020/WF-13W030
In Commercial Distribution

  • 00073950324779 ()
STW-03W020/WF-13W030

  • Oral lavage system
  • Basic electric toothbrush
Water flosser and sonic toothbrush, gray
WATER PIK, INC.
CC-04W027-1
Not in Commercial Distribution

  • 00073950314596 ()
CC-04W027-1/TCC-030

  • Oral lavage system
  • Basic electric toothbrush
Water flosser and sonic toothbrush, white
WATER PIK, INC.
CC-04W020-1
Not in Commercial Distribution

  • 00073950314572 ()
CC-04W020-1/TCC-030

  • Oral lavage system
  • Basic electric toothbrush
Water flosser and oscillating toothbrush, black
WATER PIK, INC.
CC-02CD012-2
Not in Commercial Distribution

  • 00073950233095 ()
CC-02CD012-2

  • Oral lavage system
  • Basic electric toothbrush
Water flosser and oscillating toothbrush, white
WATER PIK, INC.
CC-02CD010-1
Not in Commercial Distribution

  • 00073950233071 ()
CC-02CD010-1

  • Oral lavage system
  • Basic electric toothbrush
Water flosser and sonic toothbrush, black
WATER PIK, INC.
CC-01CD012-2
Not in Commercial Distribution

  • 00073950233057 ()
CC-01CD012-2

  • Oral lavage system
  • Basic electric toothbrush
Water flosser and sonic toothbrush, white
WATER PIK, INC.
CC-01CD010-1
Not in Commercial Distribution

  • 00073950233033 ()
CC-01CD010-1

  • Oral lavage system
  • Basic electric toothbrush
Portable Water Flosser & Electric Toothbrush Kit with Charging Stand, Power Adapter & Replaceable Brush Heads
Gurunanda, LLC
H100/H6PLUS
In Commercial Distribution

  • 00810051084313 ()


  • Oral lavage system
  • Basic electric toothbrush
NLZ BA,Control Module/Tubing ASSY/Motor Kit,68 IN,OTC
A-DEC, INC.
54.0726.00
In Commercial Distribution

  • 10194665001254 ()
54.0726.00

  • Dental surgical power tool motor, electric
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