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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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RapidCross - 00821684050712

PTA Rapid Exchange Balloon Dilatation Catheter
Covidien LP
A14BX040210090
In Commercial Distribution

  • 00821684050712 ()

  • Length: 210 Millimeter
  • Catheter Gauge: 4 French
  • Working Length,90,CM;Compatible Guidewire,0.014,IN;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT;Diameter,4-3.5,MM


  • Peripheral angioplasty balloon catheter, basic

RapidCross - 00821684050699

PTA Rapid Exchange Balloon Dilatation Catheter
Covidien LP
A14BX040120090
In Commercial Distribution

  • 00821684050699 ()

  • Length: 120 Millimeter
  • Outer Diameter: 4 Millimeter
  • Catheter Gauge: 4 French
  • Working Length,90,Centimeter;Compatible Guidewire,0.014,Inch;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT;


  • Peripheral angioplasty balloon catheter, basic

RapidCross - 00821684050651

PTA Rapid Exchange Balloon Dilatation Catheter
Covidien LP
A14BX040040090
In Commercial Distribution

  • 00821684050651 ()

  • Outer Diameter: 4 Millimeter
  • Length: 40 Millimeter
  • Working Length,90,Centimeter;Compatible Guidewire,0.014,Inch;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT;
  • Catheter Gauge: 4 French


  • Peripheral angioplasty balloon catheter, basic

RapidCross - 00821684050637

PTA Rapid Exchange Balloon Dilatation Catheter
Covidien LP
A14BX035210090
In Commercial Distribution

  • 00821684050637 ()

  • Catheter Gauge: 4 French
  • Length: 210 Millimeter
  • Working Length,90,CM;Compatible Guidewire,0.014,IN;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT;Diameter,3.5-3,MM


  • Peripheral angioplasty balloon catheter, basic

RapidCross - 00821684050613

PTA Rapid Exchange Balloon Dilatation Catheter
Covidien LP
A14BX035120090
In Commercial Distribution

  • 00821684050613 ()

  • Length: 120 Millimeter
  • Outer Diameter: 3.5 Millimeter
  • Working Length,90,Centimeter;Compatible Guidewire,0.014,Inch;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT;
  • Catheter Gauge: 4 French


  • Peripheral angioplasty balloon catheter, basic

RapidCross - 00821684050590

PTA Rapid Exchange Balloon Dilatation Catheter
Covidien LP
A14BX035080090
In Commercial Distribution

  • 00821684050590 ()

  • Outer Diameter: 3.5 Millimeter
  • Length: 80 Millimeter
  • Catheter Gauge: 4 French
  • Working Length,90,Centimeter;Compatible Guidewire,0.014,Inch;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT;


  • Peripheral angioplasty balloon catheter, basic

RapidCross - 00821684050453

PTA Rapid Exchange Balloon Dilatation Catheter
Covidien LP
A14BX025120090
In Commercial Distribution

  • 00821684050453 ()

  • Outer Diameter: 2.5 Millimeter
  • Length: 120 Millimeter
  • Catheter Gauge: 4 French
  • Working Length,90,Centimeter;Compatible Guidewire,0.014,Inch;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT;


  • Peripheral angioplasty balloon catheter, basic

RapidCross - 00821684050415

PTA Rapid Exchange Balloon Dilatation Catheter
Covidien LP
A14BX025040090
In Commercial Distribution

  • 00821684050415 ()

  • Working Length,90,Centimeter;Compatible Guidewire,0.014,Inch;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT;
  • Catheter Gauge: 4 French
  • Outer Diameter: 2.5 Millimeter
  • Length: 40 Millimeter


  • Peripheral angioplasty balloon catheter, basic

RapidCross - 00821684050392

PTA Rapid Exchange Balloon Dilatation Catheter
Covidien LP
A14BX020210090
In Commercial Distribution

  • 00821684050392 ()

  • Length: 210 Millimeter
  • Working Length,90,CM;Compatible Guidewire,0.014,IN;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT;Diameter,2-1.5,MM
  • Catheter Gauge: 4 French


  • Peripheral angioplasty balloon catheter, basic

RapidCross - 00821684050378

PTA Rapid Exchange Balloon Dilatation Catheter
Covidien LP
A14BX020120090
In Commercial Distribution

  • 00821684050378 ()

  • Working Length,90,Centimeter;Compatible Guidewire,0.014,Inch;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT;
  • Catheter Gauge: 4 French
  • Length: 120 Millimeter
  • Outer Diameter: 2 Millimeter


  • Peripheral angioplasty balloon catheter, basic

RapidCross - 00821684050354

PTA Rapid Exchange Balloon Dilatation Catheter
Covidien LP
A14BX020080090
In Commercial Distribution

  • 00821684050354 ()

  • Outer Diameter: 2 Millimeter
  • Length: 80 Millimeter
  • Catheter Gauge: 4 French
  • Working Length,90,Centimeter;Compatible Guidewire,0.014,Inch;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT;


  • Peripheral angioplasty balloon catheter, basic

RapidCross - 00821684050330

PTA Rapid Exchange Balloon Dilatation Catheter
Covidien LP
A14BX020040090
In Commercial Distribution

  • 00821684050330 ()

  • Length: 40 Millimeter
  • Outer Diameter: 2 Millimeter
  • Catheter Gauge: 4 French
  • Working Length,90,Centimeter;Compatible Guidewire,0.014,Inch;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT;


  • Peripheral angioplasty balloon catheter, basic

JBC - 04719871892251

Heat And Moisture Exchange Filters (HMEF)
FOREMOUNT ENTERPRISE CO., LTD.
400-1046/25
In Commercial Distribution

  • 04719871892251 ()


  • Heat/moisture exchanger/microbial medical gas filter

Hemoglobin Variants System - 00847817007163

Hemoglobin Variants System Cation Exchange Mini-Columns
BIO-RAD LABORATORIES, INC.
250-0014
In Commercial Distribution

  • 00847817007163 ()
2500014

  • Inherited haemoglobinopathy IVD, reagent

Hemoglobin Variants System - 00847817006791

Hemoglobin Variants System Cation Exchange Mini-Columns
BIO-RAD LABORATORIES, INC.
250-0014
In Commercial Distribution

  • 00847817006791 ()
2500014

  • Inherited haemoglobinopathy IVD, reagent

Scanner S300 - D800ERAB4061

Scanner S300 ARTI without Scansoftware "exchange"
ZIRKONZAHN SRL
ERAB4061
In Commercial Distribution

  • D800ERAB4061 ()


  • Dental milling system, CAD/CAM, laboratory

Surgical Direct - B382SD101790

11mm Trocar Screw Shaft for Exchange
Surgical Direct, Inc.
SD10179
In Commercial Distribution

  • B382SD101790 ()

  • Outer Diameter: 11 Millimeter
SD10179

  • Endoscope sheath, reusable

HydroMax HMEF - 00817081026719

HydroMax, Disposable, Heat and Moisture Exchange
A-M SYSTEMS, LLC
HydroMax HMEF - 158250
In Commercial Distribution

  • 00817081026726 ()
  • 00817081026719 ()
158250

  • Heat/moisture exchanger/microbial medical gas filter

TranS1 - 00815361020297

AxiaLIF Plus Exchange System Fixation Wire
QUANDARY MEDICAL LLC
TR1-2212
In Commercial Distribution

  • 00815361020297 ()


  • Orthopaedic bone wire

Scanner S900 - D800ERAB4051

Scanner S900 ARTI without Scansoftware "exchange"
ZIRKONZAHN SRL
ERAB4051
In Commercial Distribution

  • D800ERAB4051 ()


  • Dental milling system, CAD/CAM, laboratory

NA - 00763000123741

CUSTOM PACK CB10M30R OXY EXCHANGE P
MEDTRONIC, INC.
CB10M30R
In Commercial Distribution

  • 00763000123741 ()


  • Cardiopulmonary bypass system blood tubing set

WA Holter System - 90815187020290

HR300 Mini Holter Recorder Repair Exchange
GLOBAL INSTRUMENTATION, LLC
HR300
In Commercial Distribution

  • 90815187020290 ()
404955

  • Electrocardiographic ambulatory recorder

Xper Flex Cardio Physiomonitoring System - 00884838095069

Xper FC2010 REV E Russian Exchange
Philips Ds North America LLC
Xper FC2010 REV E Russian Exchange
In Commercial Distribution

  • 00884838095069 ()
453564845881

  • General-purpose multi-parameter bedside monitor

Xper Flex Cardio Physiomonitoring System - 00884838091498

Xper FC2010 Rev D Russia Exchange
Philips Ds North America LLC
Xper FC2010 Rev D Russia Exchange
Not in Commercial Distribution

  • 00884838091498 ()
453564674581

  • General-purpose multi-parameter bedside monitor

Welch Allyn, Inc. - 00732094009125

PROBP 3400 STANDARD W SUREBP EXCHANGE
WELCH ALLYN, INC.
901055
In Commercial Distribution

  • 00732094009125 ()
34XF-EX

  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

Merit Laureate® - 00884450236208

No Description
Merit Medical Systems, Inc.
00884450236208
In Commercial Distribution

  • 10884450236205 ()
  • 00884450236208 ()
  • 20884450236202 ()

  • Tip Shape-Straight Tip
  • Length-260 cm (102")
  • Configuration-Standard Exchange
  • Configuration-Standard Exchange; Tip Shape-Straight Tip; Length-260 cm (102"); Configuration-Standard Exchange
  • Length-260 cm (102"); Tip Shape-Straight Tip; Length-260 cm (102"); Configuration-Standard Exchange
LWSTDS35260EX/D

  • Peripheral vascular guidewire, manual

Merit Laureate® - 00884450033371

No Description
Merit Medical Systems, Inc.
00884450033371
In Commercial Distribution

  • 10884450033378 ()
  • 00884450033371 ()
  • 20884450033375 ()

  • Length-260 cm (102")
  • Configuration-Stiff Exchange
  • Tip Shape-Straight Tip
  • Tip Shape-Straight Tip; Length-260 cm (102"); Configuration-Stiff Exchange; Tip Shape-Straight Tip
  • Configuration-Stiff Exchange; Length-260 cm (102"); Configuration-Stiff Exchange; Tip Shape-Straight Tip
LWSTFS35260EX/D

  • Peripheral vascular guidewire, manual

InQwire® - 00884450022771

No Description
Merit Medical Systems, Inc.
00884450022771
In Commercial Distribution

  • 20884450022775 ()
  • 10884450022778 ()
  • 00884450022771 ()

  • Tip Shape-Straight Tip
  • Length-260 cm (102")
  • Configuration-Standard Exchange
  • Length-260 cm (102"); Tip Shape-Straight Tip; Length-260 cm (102"); Configuration-Standard Exchange
  • Configuration-Standard Exchange; Tip Shape-Straight Tip; Length-260 cm (102"); Configuration-Standard Exchange
IQ38F260S/B

  • Cardiac/peripheral vascular guidewire, single-use

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

Neuro Cochlear Implant System - 03663227001839

PACKING SET, NEURO2 ZTI EXCHANGE BOX C094
NEURELEC
181525
In Commercial Distribution

  • 03663227001839 ()


  • Cochlear implant/auditory brainstem implant sound processor

Neuro Cochlear Implant System - 03663227001815

PACKING SET, NEURO2 ZTI EXCHANGE BOX C092
NEURELEC
181523
In Commercial Distribution

  • 03663227001815 ()


  • Cochlear implant/auditory brainstem implant sound processor

Neuro Cochlear Implant System - 03663227001792

PACKING SET, NEURO2 ZTI EXCHANGE BOX C090
NEURELEC
181521
In Commercial Distribution

  • 03663227001792 ()


  • 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 - 03663227001754

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

  • 03663227001754 ()


  • Cochlear implant/auditory brainstem implant sound processor

Neuro Cochlear Implant System - 03663227001846

PACKING SET, NEURO2 ZTI EXCHANGE BOX C098
NEURELEC
181526
In Commercial Distribution

  • 03663227001846 ()


  • Cochlear implant/auditory brainstem implant sound processor

Neuro Cochlear Implant System - 03663227001822

PACKING SET, NEURO2 ZTI EXCHANGE BOX C093
NEURELEC
181524
In Commercial Distribution

  • 03663227001822 ()


  • Cochlear implant/auditory brainstem implant sound processor

Neuro Cochlear Implant System - 03663227001808

PACKING SET, NEURO2 ZTI EXCHANGE BOX C091
NEURELEC
181522
In Commercial Distribution

  • 03663227001808 ()


  • Cochlear implant/auditory brainstem implant sound processor
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