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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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At Home Drug Test for Marijuana - 00674033090781

Urine based drug of abuse test for THC
PHAMATECH, INCORPORATED
9078T
In Commercial Distribution

  • 00674033090781 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical

At Home Drug Test for Methamphetamine - 00674033090682

Urine based drug testing device for Methamphetamine
PHAMATECH, INCORPORATED
9068T
In Commercial Distribution

  • 00674033090682 ()


  • Amphetamine-specific IVD, kit, rapid ICT, clinical

Faset - 08800039825290

Awl, Cannulated
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039825290 ()
FA.IC.1001

  • Bone awl, reusable

TempoSmart - B553TEMPOSMART110

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

  • B553TEMPOSMART110 ()


  • Home pharmaceutical management support software

TempoSmart - B553TEMPOSMART100

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

  • B553TEMPOSMART100 ()


  • Home pharmaceutical management support software

Tempo Insights - B553TEMPOINSIGHTS110

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 - B553TEMPOINSIGHTS100

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

Zavation - 00842166180772

Bone Graft Tamp
Zavation LLC
290-1013
In Commercial Distribution

  • 00842166180772 ()


  • Surgical tamp, reusable

Faset - 08800039825306

K Wire Holder
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039825306 ()
FA.IN.2001

  • Surgical implant/trial-implant/sizer holder, reusable

Quintest® Covered Tray - 00365044000073

60 hole covered test tray
Jubilant Hollisterstier LLC
8930ZA
In Commercial Distribution

  • 00365044000073 ()
8930ZA

  • Allergy testing lancet
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