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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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Alice PDx - 00606959038981

Alice PDx Unit Only, Warranty Exchange, JP
Respironics, Inc.
Alice PDx Unit Only, Warranty Exchange, JP
Not in Commercial Distribution

  • 00606959038981 ()
1057626

  • Polysomnograph

Alice PDx - 00606959020689

Alice PDx Unit Only, Warranty Exchange, International
Respironics, Inc.
Alice PDx Unit Only, Warranty Exchange, INTL
In Commercial Distribution

  • 00606959020689 ()
1057624

  • Polysomnograph

Xper Flex Cardio Physiomonitoring System - 00884838086012

Xper Flex Cardio 2020 Rev D Exchange
Philips Ds North America LLC
Xper Flex Cardio 2020 Rev D Exchange
In Commercial Distribution

  • 00884838086012 ()
453564675001

  • General-purpose multi-parameter bedside monitor

Xper Flex Cardio Physiomonitoring System - 00884838093782

Xper Flex Cardio 2020 Rev E Exchange
Philips Ds North America LLC
Xper Flex Cardio 2020 Rev E Exchange
Not in Commercial Distribution

  • 00884838093782 ()
453564845861

  • General-purpose multi-parameter bedside monitor

Orthopaedic Surgical Instruments - 08059386743072

Fracture alignment guide wire exchange tool, Hudson joint
CITIEFFE SRL
Fracture align. guide wire exchange tool, Hudson
In Commercial Distribution

  • 08059386743072 ()
DT030016

  • Orthopaedic bone-fragment manipulator, reusable

Gyrus ACMI - 00821925027114

REPAIR EXCHANGE AUTOCLAVABLE SCOPE 4MM 0 DEGREES WIDE
Gyrus ACMI, LLC
REX70230910
In Commercial Distribution

  • 00821925027114 ()


  • Rigid optical sinoscope

OTOVIEW - 00821925027411

REPAIR EXCHANGE OTOVIEW SCOPE 2.4 MM 0 DEGREE
Gyrus ACMI, LLC
REX23-5210
In Commercial Distribution

  • 00821925027411 ()


  • Otoscope, endoscopic

OTOVIEW - 00821925027213

REPAIR EXCHANGE OTOVIEW SCOPE 1.7 MM 30 DEGREES
Gyrus ACMI, LLC
REX23-5201
In Commercial Distribution

  • 00821925027213 ()


  • Otoscope, endoscopic

OTOVIEW - 00821925027206

REPAIR EXCHANGE OTOVIEW SCOPE 1.7 MM 0 DEGREES
Gyrus ACMI, LLC
REX23-5200
In Commercial Distribution

  • 00821925027206 ()


  • Otoscope, endoscopic

OTOVIEW - 00821925027190

REPAIR EXCHANGE OTOVIEW SCOPE 2.4 MM 70 DEGREES
Gyrus ACMI, LLC
REX23-5212
In Commercial Distribution

  • 00821925027190 ()


  • Otoscope, endoscopic
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