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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Electric LS Package,E20 L,Expert Matic,OTC
A-DEC, INC.
54.0883.00
In Commercial Distribution

  • 10194665004545 ()
54.0883.00

  • Pneumatic dental power tool system handpiece tip, reusable
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
It is hair growing system for OTC use
Xuzhou Kernel Medical Equipment Co., Ltd.
KN-8000C
In Commercial Distribution

  • 06928798600360 ()


  • Hair growth laser device
Fentanyl Urine Test Cassette, 1T,FDA, OTC,1ng
Hangzhou AllTest Biotech Co., Ltd.
DFY-A102H
In Commercial Distribution

  • 06936983143950 ()


  • Fentanyl IVD, kit, rapid ICT, clinical
Sentibo OTC BTE Wireless Hearing Aid, Right, Beige
INTRICON CORPORATION
L155i
In Commercial Distribution

  • 00858177007571 ()
93336-011

  • Air-conduction hearing aid, behind-the-ear
Sentibo OTC BTE Wireless Hearing Aid, Left, Beige
INTRICON CORPORATION
L155i
In Commercial Distribution

  • 00858177007564 ()
93336-010

  • Air-conduction hearing aid, behind-the-ear
Amazon 10 pack of OTC 2 x 2
COMPASS HEALTH BRANDS CORP.
E1P2020BC2-TT-AMZN
In Commercial Distribution

  • 80092237616181 ()
  • 30092237616186 ()
  • 00092237616185 ()
  • 01092237616184 ()


  • Transcutaneous electrical stimulation electrode, single-use
HORMONElife™ PdG Urine Test Strip OTC 6PK
WONDFO USA CO., LTD.
W199-S-6BX
In Commercial Distribution

  • 10816862027263 ()
  • 00816862027266 ()
  • 00816862027259 ()


  • Multiple female fertility marker IVD, kit, rapid ICT, clinical
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
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
Syringe ASSY,Mini,TRAD,Non-QD,12 FT,OTC,INTL
A-DEC, INC.
23.1376.01
In Commercial Distribution

  • 10194665002268 ()
23.1376.01

  • Dental delivery system irrigation handpiece
Electric Motor Kit,Nano,Control Module,68 IN,OTC
A-DEC, INC.
54.0727.00
In Commercial Distribution

  • 10194665005467 ()
54.0727.00

  • Remotely-driven surgical/dental system drive cable
Tip,HVE,90 Degree,Square Ends,Passivated SST,OTC
A-DEC, INC.
10.0015.00
In Commercial Distribution

  • 10194665004583 ()
10.0015.00

  • Dental suction system cannula, single-use
Syringe ASST,Mini,TRAD,Non-QD,12 FT,OTC,China
A-DEC, INC.
23.1376.02
In Commercial Distribution

  • 10194665002275 ()
23.1376.02

  • Dental delivery system irrigation handpiece
Syringe ASSY Mini,TRAD,Non-QD,7 FT,OTC,INTL
A-DEC, INC.
23.1375.01
In Commercial Distribution

  • 10194665002237 ()
23.1375.01

  • Dental delivery system irrigation handpiece
NLZ,Tubing ASSY/Electric Motor Kit,68 IN,OTC
A-DEC, INC.
54.0726.01
In Commercial Distribution

  • 10194665001261 ()
54.0726.01

  • Dental surgical power tool motor, electric
NLZ,Tubing ASSY/Electric Motor Kit,82 IN,OTC
A-DEC, INC.
54.0606.01
In Commercial Distribution

  • 10194665001070 ()
54.0606.01

  • Dental surgical power tool motor, electric
NLZ,Tubing ASSY/Electric Motor Kit,63 IN, OTC
A-DEC, INC.
54.0605.01
In Commercial Distribution

  • 10194665001056 ()
54.0605.01

  • Dental surgical power tool motor, electric
Electric Motor Kit,Nano,Control Module,82 IN,OTC
A-DEC, INC.
54.0447.00
In Commercial Distribution

  • 10194665000820 ()
54.0477.00

  • Dental surgical power tool motor, electric
Electric Motor Kit,Nano,Control Module,61 IN,OTC
A-DEC, INC.
54.0446.00
In Commercial Distribution

  • 10194665000608 ()
54.0446.00

  • Dental surgical power tool motor, electric
Fentanyl Urine Test Cassette, 1T*6,FDA, OTC,1ng
Hangzhou AllTest Biotech Co., Ltd.
DFY-A102H
In Commercial Distribution

  • 06936983144650 ()
  • 06936983143950 ()


  • Fentanyl IVD, kit, rapid ICT, clinical
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
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
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
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
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
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