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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AQUIOS Tetra-1 Panel CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5
BECKMAN COULTER IRELAND INC.
B23533
In Commercial Distribution

  • 15099590225704 ()
B23533

  • Multiple CD cell marker IVD, antibody
No Description
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution

  • 06952804801823 ()


  • Amphetamine-specific IVD, kit, rapid ICT, clinical
No Description
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution

  • 06952804801816 ()


  • Benzodiazepine group IVD, kit, rapid ICT, clinical
No Description
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution

  • 06952804801809 ()


  • Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
No Description
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution

  • 06952804801793 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
No Description
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution

  • 06952804801786 ()


  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
No Description
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution

  • 06952804801779 ()


  • Amphetamine-specific IVD, kit, rapid ICT, clinical
No Description
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution

  • 06952804801762 ()


  • Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
No Description
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution

  • 06952804801755 ()


  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
No Description
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution

  • 06952804801748 ()


  • Amphetamine-specific IVD, kit, rapid ICT, clinical
No Description
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution

  • 06952804801731 ()


  • Methadone IVD, kit, rapid ICT, clinical
No Description
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution

  • 06952804801724 ()


  • Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
No Description
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution

  • 06952804801717 ()


  • Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
No Description
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution

  • 06952804801700 ()


  • Barbiturate IVD, kit, rapid ICT, clinical
Web application
MC10, INC.
SW-0043
Not in Commercial Distribution

  • B493SW0043 ()


  • Electronic goniometer/kinesiology sensor
  • Kinesiology ambulatory recorder
  • Biomechanical function analysis/rehabilitation software
Patient application for Android
MC10, INC.
SW-0042
Not in Commercial Distribution

  • B493SW0042 ()


  • Electronic goniometer/kinesiology sensor
  • Kinesiology ambulatory recorder
  • Biomechanical function analysis/rehabilitation software
Instructions for use
MC10, INC.
MC-0016
Not in Commercial Distribution

  • B493MC0016 ()


  • Electronic goniometer/kinesiology sensor
  • Kinesiology ambulatory recorder
  • Biomechanical function analysis/rehabilitation software
MC-0011 kit containing DIs B493BRCS02, B493BRCD02, B493BRCP03, B493BSPS01, B493BRCA05, B493MC0009
MC10, INC.
MC-0011
Not in Commercial Distribution

  • B493MC0011 ()


  • Kinesiology ambulatory recorder
  • Biomechanical function analysis/rehabilitation software
  • Electronic goniometer/kinesiology sensor
DAU+ V2 F OT
UTAK LABORATORIES, INC.
URINE PAIN PANEL
In Commercial Distribution

  • B800DAUV2FOT5 ()
  • B800DAUV2FOT0 ()

  • Total Volume: 1 Milliliter
URINE PAIN PANEL

  • Multiple-type clinical chemistry analyte profile IVD, control
6PLUS1® Multilevel Serum Calibrator Set MassChrom® Steroid Panel 1 and Panel 2
Chromsystems Instruments + Chemicals GmbH
72040
In Commercial Distribution

  • 04250317539717 ()

  • Total Volume: 3 Milliliter
  • 7 Vials
72040

  • Multiple steroid hormone IVD, calibrator
Fully-contained mobile dental unit and accessories. The AC-powered device Is intended to supply power and to serve as a base for other dental devices such as a dental handpiece, and other dental devices and accessories.
Safari Dentaire Inc
SAF-430
In Commercial Distribution

  • D104SAF430 ()


  • Dental delivery system instrument unit, electric
Fully-contained mobile dental unit and accessories. The AC-powered device Is intended to supply power and to serve as a base for other dental devices such as a dental handpiece, and other dental devices and accessories.
Safari Dentaire Inc
SAF-606-4.6
In Commercial Distribution

  • D104SAF60646 ()


  • Dental delivery system instrument unit, electric
Fully-contained mobile dental unit and accessories. The AC-powered device Is intended to supply power and to serve as a base for other dental devices such as a dental handpiece, and other dental devices and accessories.
Safari Dentaire Inc
SAF-606-2.6
In Commercial Distribution

  • D104SAF60626 ()


  • Dental delivery system instrument unit, electric
Fully-contained mobile dental unit and accessories. The AC-powered device Is intended to supply power and to serve as a base for other dental devices such as a dental handpiece, and other dental devices and accessories.
Safari Dentaire Inc
SAF-531-Series II
In Commercial Distribution

  • D104SAF531SERIES2 ()


  • Dental delivery system instrument unit, electric
Fully-contained mobile dental unit and accessories. The AC-powered device Is intended to supply power and to serve as a base for other dental devices such as a dental handpiece, and other dental devices and accessories.
Safari Dentaire Inc
SAF-500-M4
In Commercial Distribution

  • D104SAF500M4 ()


  • Dental delivery system instrument unit, electric
Fully-contained mobile dental unit and accessories. The AC-powered device Is intended to supply power and to serve as a base for other dental devices such as a dental handpiece, and other dental devices and accessories.
Safari Dentaire Inc
SAF-500-M2
In Commercial Distribution

  • D104SAF500M2 ()


  • Dental delivery system instrument unit, electric
Fully-contained mobile dental unit and accessories. The AC-powered device Is intended to supply power and to serve as a base for other dental devices such as a dental handpiece, and other dental devices and accessories.
Safari Dentaire Inc
SAF-500-CART
In Commercial Distribution

  • D104SAF500CART0 ()
SAF-500-CART

  • Dental delivery system instrument unit, electric
Fully-contained mobile dental unit and accessories. The AC-powered device Is intended to supply power and to serve as a base for other dental devices such as a dental handpiece, and other dental devices and accessories.
Safari Dentaire Inc
SAF-470
In Commercial Distribution

  • D104SAF470 ()


  • Dental delivery system instrument unit, electric
Fully-contained mobile dental unit and accessories. The AC-powered device Is intended to supply power and to serve as a base for other dental devices such as a dental handpiece, and other dental devices and accessories.
Safari Dentaire Inc
SAF-430-2XP
In Commercial Distribution

  • D104SAF433XP0 ()


  • Dental delivery system instrument unit, electric
Fully-contained mobile dental unit and accessories. The AC-powered device Is intended to supply power and to serve as a base for other dental devices such as a dental handpiece, and other dental devices and accessories.
Safari Dentaire Inc
SAF-430-2
In Commercial Distribution

  • D104SAF4303 ()


  • Dental delivery system instrument unit, electric
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