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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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PLASTIC WEDGES WITH HOLE - D89260705415271

No Description
MAXILL, INC.
6070541527
In Commercial Distribution

  • D89260705415270 ()
  • D89260705415271 ()


  • Dental wedge, single-use

PLASTIC WEDGES WITH HOLE - D89260705415261

No Description
MAXILL, INC.
6070541526
In Commercial Distribution

  • D89260705415260 ()
  • D89260705415261 ()


  • Dental wedge, single-use

Air Flex with Auto-Distraction - 00860001452525

No Description
HILL LABORATORIES CO.
Air Flex II with Auto-Distraction
In Commercial Distribution

  • 00860001452525 ()


  • Body arch traction table

iReveal with PowerLook AMP - 00858012005656

PowerLook Density Assessment software application intended for use with digital mammography systems. PowerLook Density Assessment calculates breast density as a ratio of fibroglandular tissue and total breast area estimates. PowerLook Density Assessment provides these numerical values for each breast as well as a density category to aid radiologists in the assessment of breast tissue composition. PowerLook Density Assessment produces adjunctive information. It is not an interpretive or diagnostic aid.
Icad, Inc.
V2.1
In Commercial Distribution

  • 00858012005656 ()
DSC012

  • Basic diagnostic x-ray system application software

Cognivue Advanced with Cart - 00860000564007

No Description
COGNIVUE, INC.
Cart Unit
In Commercial Distribution

  • 00860000564007 ()


  • Cognitive assessment software

AP70(with long antenna) - 06936415973537

No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
115-071010-00
In Commercial Distribution

  • 06936415973537 ()


  • General-purpose multi-parameter bedside monitor

Tip with Indexable Stop - 08057639710574

Tip with Indexable Stop for MCBio Tacks
MC BIO SRL
9570566
In Commercial Distribution

  • 08057639710574 ()


  • Bone tack inserter, basic

Bracket with Tube Guide - 00709078013560

Bracket with Tube Guide
WESTMED, INC.
WP-7704
In Commercial Distribution

  • 10709078013574 ()
  • 00709078013560 ()


  • PEEP valve, single-use

Cobalt MV with Gentamicin - 00880304476783

No Description
Biomet Orthopedics, LLC
402439
In Commercial Distribution

  • 00880304476783 ()
402439

  • Orthopaedic cement, antimicrobial

Perfusion Clamp with Adaptor - 13700911900942

The Perfusion Clamp is used for explanted organ recovered with aortic patch. It is a sterile, disposable and single-use device.
INSTITUT GEORGES LOPEZ
PC1025A
In Commercial Distribution

  • 23700911900949 ()
  • 13700911900942 ()
  • 53700911900940 ()
  • 33700911900946 ()


  • Kidney donor-organ preservation/transport perfusion set
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