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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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Intima Sterile 2 Internal + 1 External HP, Accessories Kit
Candela Corporation
KT78011
In Commercial Distribution

KT78011

  • Dermatological laser beam guiding handpiece
AccuDrain® External CSF Drainage System with Anti-Reflux Valve
Integra Lifesciences Corporation
INS8401
In Commercial Distribution

  • 10381780023883 ()
  • M269INS84011 ()

  • 700ml drainage bag, 75ml burette chamber, 150cm green striped tubing line
INS8401

  • Lumbar cerebrospinal fluid drainage catheterization kit
  • Ventricular cerebrospinal fluid drainage catheterization kit
Curaplex Automated External Defibrillator (AED) Kit in Yellow Pouch
BOUND TREE MEDICAL, LLC
651777
In Commercial Distribution

  • 00815277021210 ()
  • 00810071639272 ()
651777

  • Nitrile examination/treatment glove, non-powdered, antimicrobial
  • Safety razor, single-use
  • Antiseptic skin towelette
  • Cardiopulmonary resuscitation mask, single-use
  • Dry medical towel/wipe, single-use
  • Bandage scissors, reusable
  • Laboratory waste receptacle IVD
CODMAN® EDS 3™ CSF External Drainage System
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
821731C
In Commercial Distribution

  • 10381780518327 ()
82-1731C

  • Ventricular cerebrospinal fluid drainage catheterization kit
Intima Sterile 2 Internal + 1 External HP, Accessories Kit
SYNERON MEDICAL LTD
KT78011
Not in Commercial Distribution

  • 07290109952857 ()


  • Dermatological laser beam guiding handpiece
NPr Ab Ti Biomet 3i External Hex 3.4 w-u
Nobel Biocare AB
70175
Not in Commercial Distribution

  • 07332747101522 ()
70175

  • Dental implant suprastructure, permanent, preformed
NPr Ab Ti Biomet 3i External Hex 5.0 w-u
Nobel Biocare AB
70176
Not in Commercial Distribution

  • 07332747101515 ()
70176

  • Dental implant suprastructure, permanent, preformed
NPr Ab Ti Biomet 3i External Hex 6.0 w-u
Nobel Biocare AB
70177
Not in Commercial Distribution

  • 07332747101508 ()
70177

  • Dental implant suprastructure, permanent, preformed
NPr Ab Ti Biomet 3i External Hex 4.1 w-u
Nobel Biocare AB
70178
Not in Commercial Distribution

  • 07332747101492 ()
70178

  • Dental implant suprastructure, permanent, preformed
Wide dia. impression coping for open tray external hex.
MIS Implants Technologies Ltd.
EW-I0500
Not in Commercial Distribution

  • 07290109016009 ()
EW-I0500

  • Dental implant suprastructure, temporary, preformed, single-use
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