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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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No Description
Orasure Technologies, Inc.
1103IB
In Commercial Distribution

  • 00608337000146 ()


  • Amphetamine-specific IVD, kit, enzyme immunoassay (EIA)
This is a medical device.This is a medical device.
KaVo Dental GmbH
0.571.5171
In Commercial Distribution

  • EKAV057151710 ()
scaler Tip No 5

  • Ultrasonic dental scaling/debridement system
No Description
KaVo Dental GmbH
0.571.0472
In Commercial Distribution

  • EKAV057104720 ()
clean Brush No 5

  • Ultrasonic dental scaling/debridement system
A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
ENZTEC LIMITED
4252-2367
In Commercial Distribution

  • 09421028119900 ()
4252-2367

  • Orthopaedic implant impactor, reusable
No Description
Philips Ultrasound LLC
795120
In Commercial Distribution

  • 00884838097858 ()


  • General-purpose ultrasound imaging system
No Description
Respironics Novametrix, LLC
00
In Commercial Distribution

  • 00884838082267 ()
1050549

  • Patient monitoring system module, carbon dioxide
No Description
Respironics Novametrix, LLC
00
In Commercial Distribution

  • 00884838082250 ()
1036698

  • Patient monitoring system module, carbon dioxide
Software version-10.0.X
Philips Ultrasound LLC
795204
In Commercial Distribution

  • 00884838114111 ()


  • General-purpose ultrasound imaging system
Software Version 9.X
Philips Ultrasound LLC
795120
In Commercial Distribution

  • 00884838113886 ()


  • General-purpose ultrasound imaging system
No Description
DIAGNOSTICA STAGO
00595
In Commercial Distribution

  • 13607450005957 ()
  • 03607450005950 ()


  • Activated partial thromboplastin time (APTT) IVD, kit, clotting
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