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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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ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution

  • 06952804801182 ()


  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
HEMOCELL Soluble Dental Gauze Dressing
Huizhou Foryou Medical Devices Co., Ltd.
2×2cm
In Commercial Distribution

  • 16940610101760 ()
  • 26940610101767 ()
  • 36940610101764 ()


  • General oral wound dressing, non-animal-derived, sterile
No Description
ALERE SAN DIEGO, INC.
DPC-101-a-Sgl
In Commercial Distribution

  • 10810124273245 ()
  • 00810124273248 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 1 PCP
REDWOOD TOXICOLOGY LABORATORY, INC.
011020021
In Commercial Distribution

  • 10858904006089 ()
  • 00858904006082 ()
DPC-114-OBC12B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
The NSS Neurostim ((510)K140530) is a percutaneous nerve field stimulator (PNFS) system, which is used in a target population of acute and/or chronic pain. The NSS Neurostim is a battery-operated micro-stimulation appliance weighing approximately 5 grams designed as a disposable product for a single use. The NSS Neurostim is placed behind the patient’s ear and connected to stimulation needles on the auricle. The NSS Neurostim offers regular therapy over several days. The appliance transmits low-frequency electric pulses to exposed nerve endings.
KEY ELECTRONICS, INC.
Neurostim
In Commercial Distribution

  • B327NSS201 ()
  • B327NSS2012 ()
  • B327NSS2011 ()
01-1021

  • Acupuncture electrical stimulation system
Tempo Insights™ is the healthcare provider-facing component of TempoSmart. Neither Tempo Insights nor TempoSmart is intended to replace the research, expertise, judgment, or treatment provided to patients by healthcare providers. TempoSmart™ is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. TempoSmart is intended to assist patients in managing their diabetes with guidance from their providers.
WELLDOC, INC.
v1.1
In Commercial Distribution

  • B553TEMPOINSIGHTS110 ()


  • Home pharmaceutical management support software
Tempo Insights™ is the healthcare provider-facing component of TempoSmart. Neither Tempo Insights nor TempoSmart is intended to replace the research, expertise, judgment, or treatment provided to patients by healthcare providers. TempoSmart™ is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. TempoSmart is intended to assist patients in managing their diabetes with guidance from their providers.
WELLDOC, INC.
v1.0
Not in Commercial Distribution

  • B553TEMPOINSIGHTS100 ()


  • Home pharmaceutical management support software
The AXUS ES-5 is an electro-acupuncture device indicated for use in the practice of acupuncture by qualified professionals of acupuncture as determined by the state. The AXUS ES-5 is a battery operated prescription use only electro-acupuncture device used for applying electric stimuli to areas of preferred delivery (APD). The device uses a low-intensity, low-frequency pulse multimode generator through micro-alligator clips attached to commercially available and FDA-cleared stainless steel acupuncture needles. The device can also deliver stimulation with the included probe.
TENS PLUS INDUSTRIAL COMPANY
ED3930
In Commercial Distribution

  • 14897076720092 ()
ED3930

  • Analgesic transcutaneous electrical nerve stimulation system
5cm x 5cm Placental ECM
Triad Life Sciences, Inc.
IMX-0505-01
In Commercial Distribution

  • 00850002643176 ()
IMX-0505-01

  • Wound compression dressing
4cm x 4cm Placental ECM
Triad Life Sciences, Inc.
IMX-0404-01
In Commercial Distribution

  • 00850002643169 ()
IMX-0404-01

  • Wound compression dressing
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