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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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Sprint Quattro Secure S™ - 00763000180010

LEAD 693552 SPRINT US RCMCRD
MEDTRONIC, INC.
693552
In Commercial Distribution

  • 00763000180010 ()

  • Length: 52.0 Centimeter


  • Endocardial defibrillation lead

DiamondTemp™ Irrigation Tubing Set - 00763000687984

TUBING SET CEDTTS100 5PK US/CAN
MEDTRONIC, INC.
CEDTTS100
In Commercial Distribution

  • 20763000687988 ()
  • 00763000687984 ()


  • Cardiac ablation system irrigation tubing set

Epsila EV™ MRI SureScan™ - 00763000369781

LEAD EV240163 SUBSTERNAL LEAD 63CM
MEDTRONIC, INC.
EV240163
In Commercial Distribution

  • 00763000369781 ()

  • Length: 63.0 Centimeter


  • Endocardial defibrillation lead

Epsila EV™ MRI SureScan™ - 00763000369767

LEAD EV240152 SUBSTERNAL LEAD 52CM
MEDTRONIC, INC.
EV240152
In Commercial Distribution

  • 00763000369767 ()

  • Length: 52.0 Centimeter


  • Endocardial defibrillation lead

DiamondTemp™ Irrigation Tubing Set - 00763000482169

TUBING SET CEDTTS100 5PK US
MEDTRONIC, INC.
CEDTTS100
In Commercial Distribution

  • 20763000482163 ()
  • 00763000482169 ()


  • Cardiac ablation system irrigation tubing set

N/A - 00763000995003

TUBING SET AFR-00002 HEXAFLOW 4PK US
MEDTRONIC, INC.
AFR-00002
In Commercial Distribution

  • 20763000995007 ()
  • 00763000995003 ()


  • Cardiac ablation system irrigation tubing set

NA - 00763000871772

TUBING SET AFR-00002 HEXAFLOW 4PK US
MEDTRONIC, INC.
AFR-00002
In Commercial Distribution

  • 20763000871776 ()
  • 00763000871772 ()


  • Cardiac ablation system irrigation tubing set

Prometra Programmer - 00810335020167

The Prometra Programmer is a non-sterile handheld menu driven device, external to the implanted pump that enables remote programming of the implantable Programmable Pump using a touchscreen interface. The Programmer can program the pump to deliver a precise flow of medication at a constant or variable rate, or it can be set to periodically deliver a drug dosage at distinct intervals of time (i.e., Periodic Flow Mode). There is also an option to interrupt the pump's current medication regimen and deliver an immediate infusion of medication (Demand Bolus).
Flowonix Medical, Inc.
12828
In Commercial Distribution

  • 00810335020167 ()


  • Infusion pump programmer

PEMF - PHYSIO-STIM - 18257200136001

5315CMD, DEMO, BONE GROWTH STIMULATOR, PHYSIOSTIM, CM
Orthofix US LLC
655315-0006
In Commercial Distribution

  • 18257200136001 ()
5315CMD

  • Flexible video laryngoscope

PEMF - PHYSIO-STIM - 18257200135998

5315CED, DEMO, BONE GROWTH STIMULATOR, PHYSIOSTIM, CE
Orthofix US LLC
655315-0004
In Commercial Distribution

  • 18257200135998 ()
5315CED

  • Flexible video laryngoscope
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