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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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GEN4 PLUS, RESPONDER 5, ENHANCED
CURBELL MEDICAL PRODUCTS, INC.
5C410U-00100000A
In Commercial Distribution

  • 00840828171687 ()
24317

  • Pillow speaker
RESPONDER 5, STANDARD,NO ENTERTAINMENT
CURBELL MEDICAL PRODUCTS, INC.
4D411U-201000F
In Commercial Distribution

  • 00840828143745 ()
19210

  • Pillow speaker
MaxG 4mm Adapter 5 pack
Cynosure, LLC
2520-0035
In Commercial Distribution

  • 10841494108059 ()
  • 00841494108052 ()


  • Light-energy skin surface treatment system applicator
No Description
HELENA LABORATORIES CORPORATION
5069
In Commercial Distribution

  • M52550690 ()


  • Protein electrophoresis IVD, control
Light Based Over-The-Counter Hair Removal
PROCTER & GAMBLE MANUFACTURING COMPANY, THE
BD5006
In Commercial Distribution

  • 10069055882426 ()
  • 00069055882405 ()


  • Cosmetic red-light phototherapy system, home-use
The Showmotion UPPER 5 kit includes 5 WISE sensors, a GATEWAY receiver, elastic bands and a charger. The platform allows to carry out the kinematic analysis of the movement of the upper district.
NCS LAB SRL
SHWM01U5
In Commercial Distribution

  • 08051122041022 ()


  • Kinesiology/electromyographic sensor set
StatusFirst™ ME/O(2K)/C/TH/P card; 25 Test kit; for reader
PRINCETON BIOMEDITECH CORPORATION
DOA-251-25-02
In Commercial Distribution

  • 10743816000396 ()
DOA-251-25-02

  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
4mm AdvanSync Spacer, Pk/5
ALLESEE AOA-PRO
MATER207
In Commercial Distribution

  • 10889989083252 ()
  • 00889989083255 ()


  • Orthodontic clasp, metal, custom-made
No Description
Roche Diagnostics GmbH
11893467160
In Commercial Distribution

  • 00075537018934 ()
11893467160

  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical
Omron Blood Pressure Monitor, 5 Series
Omron Healthcare, Inc.
BP742CANN
In Commercial Distribution

  • 00073796742348 ()
  • 10073796742345 ()
BP742CANN

  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
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