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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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Neuro Cochlear Implant System - 03663227001785

PACKING SET, NEURO2 ZTI EXCHANGE BOX C063
NEURELEC
181520
In Commercial Distribution

  • 03663227001785 ()


  • Cochlear implant/auditory brainstem implant sound processor

Neuro Cochlear Implant System - 03663227001778

PACKING SET, NEURO2 ZTI EXCHANGE BOX C058
NEURELEC
181519
In Commercial Distribution

  • 03663227001778 ()


  • Cochlear implant/auditory brainstem implant sound processor

Neuro Cochlear Implant System - 03663227001761

PACKING SET, NEURO2 ZTI EXCHANGE BOX C057
NEURELEC
181518
In Commercial Distribution

  • 03663227001761 ()


  • Cochlear implant/auditory brainstem implant sound processor

Neuro Cochlear Implant System - 03663227001754

PACKING SET, NEURO2 ZTI EXCHANGE BOX C044
NEURELEC
181517
In Commercial Distribution

  • 03663227001754 ()


  • Cochlear implant/auditory brainstem implant sound processor

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

OXFORD ANKLE FUSION NAIL(AFN) SYSTEM - 05055662944761

OXBRIDGE AFN DISPOSABLES - DRILLS / PIN & EXCHANGE TUBE
ORTHO SOLUTIONS HOLDINGS LIMITED
OS333013
In Commercial Distribution

  • 05055662944761 ()
OS333013

  • Joint prosthesis implantation kit, single-use

OXFORD ANKLE FUSION NAIL(AFN) SYSTEM - 05055662962420

OXBRIDGE AFN DISPOSABLES - DRILLS / PIN & EXCHANGE TUBE
ORTHO SOLUTIONS HOLDINGS LIMITED
OS333013
In Commercial Distribution

  • 05055662962420 ()
OS333013

  • Joint prosthesis implantation kit, single-use

ARROW - 00801902001375

RIC(R) Rapid Infusion Catheter Exchange Set
TELEFLEX INCORPORATED
IPN033579
In Commercial Distribution

  • 30801902001376 ()
  • 00801902001375 ()
RC-09850

  • Vascular catheter introduction set, nonimplantable

ARROW - 00801902001368

RIC(R) Rapid Infusion Catheter Exchange Set
TELEFLEX INCORPORATED
IPN033577
In Commercial Distribution

  • 30801902001369 ()
  • 00801902001368 ()
RC-09700

  • Vascular catheter introduction set, nonimplantable

ARROW - 00801902101525

RIC(R) Rapid Infusion Catheter Exchange Set
TELEFLEX INCORPORATED
IPN033580
In Commercial Distribution

  • 30801902101526 ()
  • 00801902101525 ()
RC-09850

  • Vascular catheter introduction set, nonimplantable

ARROW - 00801902101518

RIC(R) Rapid Infusion Catheter Exchange Set
TELEFLEX INCORPORATED
IPN033578
In Commercial Distribution

  • 30801902101519 ()
  • 00801902101518 ()
RC-09700

  • Vascular catheter introduction set, nonimplantable

ARROW - 10801902221343

RIC(R) Rapid Infusion Catheter Exchange Set
TELEFLEX INCORPORATED
IPN930196
In Commercial Distribution

  • 20801902221340 ()
  • 10801902221343 ()
RC-09850

  • Vascular catheter introduction set, nonimplantable

ARROW - 10801902221336

RIC(R) Rapid Infusion Catheter Exchange Set
TELEFLEX INCORPORATED
IPN930195
In Commercial Distribution

  • 20801902221333 ()
  • 10801902221336 ()
RC-09700

  • Vascular catheter introduction set, nonimplantable

ARROW - 10801902207125

RIC(R) Rapid Infusion Catheter Exchange Set
TELEFLEX INCORPORATED
IPN923914
In Commercial Distribution

  • 20801902207122 ()
  • 10801902207125 ()
RC-09850

  • Vascular catheter introduction set, nonimplantable

ARROW - 10801902207118

RIC(R) Rapid Infusion Catheter Exchange Set
TELEFLEX INCORPORATED
IPN923913
In Commercial Distribution

  • 20801902207115 ()
  • 10801902207118 ()
RC-09700

  • Vascular catheter introduction set, nonimplantable

The Firm - 00827002116672

The Firm PC Exchange Wire Guide Curved
COOK INCORPORATED
G11667
In Commercial Distribution

  • 00827002116672 ()
RPC-35-260-2-CONNORS

  • Peripheral vascular guidewire, manual

Cook - 00827002576285

Cook Airway Exchange Catheter with Rapi-Fit Adapters
COOK INCORPORATED
G57628
In Commercial Distribution

  • 00827002576285 ()
C-CAE-14.0-100-DLT-EF-ST-01

  • Endotracheal tube guide, single-use

Cook - 00827002576278

Cook Airway Exchange Catheter with Rapi-Fit Adapters
COOK INCORPORATED
G57627
In Commercial Distribution

  • 00827002576278 ()
C-CAE-11.0-100-DLT-EF-ST-01

  • Endotracheal tube guide, single-use

Cook - 00827002576247

Cook Airway Exchange Catheter with Rapi-Fit Adapters
COOK INCORPORATED
G57624
In Commercial Distribution

  • 00827002576247 ()
C-CAE-8.0-45-01

  • Endotracheal tube guide, single-use

Cook - 00827002576230

Cook Airway Exchange Catheter with Rapi-Fit Adapters
COOK INCORPORATED
G57623
In Commercial Distribution

  • 00827002576230 ()
C-CAE-19.0-83-01

  • Endotracheal tube guide, single-use

Cook - 00827002576223

Cook Airway Exchange Catheter with Rapi-Fit Adapters
COOK INCORPORATED
G57622
In Commercial Distribution

  • 00827002576223 ()
C-CAE-14.0-83-01

  • Endotracheal tube guide, single-use

Cook - 00827002576216

Cook Airway Exchange Catheter with Rapi-Fit Adapters
COOK INCORPORATED
G57621
In Commercial Distribution

  • 00827002576216 ()
C-CAE-11.0-83-01

  • Endotracheal tube guide, single-use

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

AMICUS Exchange Kit - Therapeutics - 04086000101950

For Therapeutic Plasma Exchange (TPE) Procedure. For Red Blood Cell Exchange (RBCX) Procedures. For Use with the AMICUS Separator. Sterile Fluid Path.
Fresenius Kabi AG
X6R2349
In Commercial Distribution

  • 04086000101950 ()
  • 14086000101957 ()
X6R2349

  • Therapeutic plasma/red blood cell exchange tubing set

InQwire® Amplatz - 00884450239476

No Description
Merit Medical Systems, Inc.
00884450239476
In Commercial Distribution

  • 10884450239473 ()
  • 00884450239476 ()
  • 20884450239470 ()

  • Tip Shape-3 mm J-Tip
  • Length-260 cm (102")
  • Configuration-Amplatz Exchange
  • Length-260 cm (102"); Tip Shape-3 mm J-Tip; Length-260 cm (102"); Configuration-Amplatz Exchange
  • Configuration-Amplatz Exchange; Tip Shape-3 mm J-Tip; Length-260 cm (102"); Configuration-Amplatz Exchange
IQA502

  • Cardiac/peripheral vascular guidewire, single-use

InQwire® - 00884450198827

No Description
Merit Medical Systems, Inc.
00884450198827
In Commercial Distribution

  • 20884450198821 ()
  • 10884450198824 ()
  • 00884450198827 ()

  • Length-260 cm (102")
  • Tip Shape-1.5 mm J-Tip
  • Configuration-Standard Exchange
  • Tip Shape-1.5 mm J-Tip; Length-260 cm (102"); Tip Shape-1.5 mm J-Tip; Configuration-Standard Exchange
  • Configuration-Standard Exchange; Length-260 cm (102"); Tip Shape-1.5 mm J-Tip; Configuration-Standard Exchange
IQ35F260J1O5/B

  • Cardiac/peripheral vascular guidewire, single-use

InQwire® - 00884450011133

No Description
Merit Medical Systems, Inc.
00884450011133
In Commercial Distribution

  • 20884450011137 ()
  • 10884450011130 ()
  • 00884450011133 ()

  • Length-260 cm (102")
  • Configuration-Standard Exchange
  • Tip Shape-3 mm J-Tip
  • Configuration-Standard Exchange; Length-260 cm (102"); Configuration-Standard Exchange; Tip Shape-3 mm J-Tip
  • Tip Shape-3 mm J-Tip; Length-260 cm (102"); Configuration-Standard Exchange; Tip Shape-3 mm J-Tip
IQ35F260J3/B

  • Cardiac/peripheral vascular guidewire, single-use

InQwire® - 00884450004333

No Description
Merit Medical Systems, Inc.
00884450004333
In Commercial Distribution

  • 20884450004337 ()
  • 10884450004330 ()
  • 00884450004333 ()

  • Length-260 cm (102")
  • Tip Shape-3 mm J-Tip
  • Configuration-Standard Exchange
  • Configuration-Standard Exchange; Length-260 cm (102"); Tip Shape-3 mm J-Tip; Configuration-Standard Exchange
  • Tip Shape-3 mm J-Tip; Length-260 cm (102"); Tip Shape-3 mm J-Tip; Configuration-Standard Exchange
IQ38F260J3/B

  • Cardiac/peripheral vascular guidewire, single-use

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

OTOVIEW - 00821925027183

REPAIR EXCHANGE OTOVIEW SCOPE 2.4 MM 30 DEGREES
Gyrus ACMI, LLC
REX23-5211
In Commercial Distribution

  • 00821925027183 ()


  • Otoscope, endoscopic

Gyrus ACMI - 00821925027138

REPAIR EXCHANGE AUTOCLAVABLE SINUSCOPE 45 DEGREE, 4 MM
Gyrus ACMI, LLC
REX70230917
In Commercial Distribution

  • 00821925027138 ()


  • Rigid optical sinoscope

Zilver 518 - 10827002493336

Zilver 518RX Vascular Stent, Rapid Exchange Self-Expanding Stent
COOK IRELAND LTD
G49333
Not in Commercial Distribution

  • 10827002493336 ()
ZIVX5-18-125-10-80

  • Peripheral artery stent, bare-metal

Zilver 518 - 10827002493329

Zilver 518RX Vascular Stent, Rapid Exchange Self-Expanding Stent
COOK IRELAND LTD
G49332
Not in Commercial Distribution

  • 10827002493329 ()
ZIVX5-18-125-10-60

  • Peripheral artery stent, bare-metal
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