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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Hemagard Carotid Patch Knitted Ultrathin Collagen Coated Vascular Patch
INTERVASCULAR SAS
HGK12/75CPUT (1)
In Commercial Distribution

  • 00384401014935 ()

  • Width: 12 Millimeter
  • Length: 75 Millimeter
HGK12/75CPUT (1)

  • Cardiovascular patch, animal-derived
Hemagard Carotid Patch Knitted Ultrathin Collagen Coated Vascular Patch
INTERVASCULAR SAS
HGK10/75CPUT (1)
In Commercial Distribution

  • 00384401014928 ()

  • Width: 10 Millimeter
  • Length: 75 Millimeter
HGK10/75CPUT (1)

  • Cardiovascular patch, animal-derived
Hemagard Carotid Patch Knitted Collagen Coated Vascular Patch
INTERVASCULAR SAS
HGK14/75CP (1)
In Commercial Distribution

  • 00384401014911 ()

  • Width: 14 Millimeter
  • Length: 75 Millimeter
HGK14/75CP (1)

  • Cardiovascular patch, animal-derived
Hemagard Carotid Patch Knitted Collagen Coated Vascular Patch
INTERVASCULAR SAS
HGK12/75CP (1)
In Commercial Distribution

  • 00384401014904 ()

  • Width: 12 Millimeter
  • Length: 75 Millimeter
HGK12/75CP (1)

  • Cardiovascular patch, animal-derived
Hemagard Carotid Patch Knitted Collagen Coated Vascular Patch
INTERVASCULAR SAS
HGK10/75CP (1)
In Commercial Distribution

  • 00384401014898 ()

  • Width: 10 Millimeter
  • Length: 75 Millimeter
HGK10/75CP (1)

  • Cardiovascular patch, animal-derived
Hemagard Patch Knitted Collagen Coated Vascular Patch
INTERVASCULAR SAS
HGK20/140P (1)
In Commercial Distribution

  • 00384401014881 ()

  • Width: 20 Millimeter
  • Length: 140 Millimeter
HGK20/140P (1)

  • Cardiovascular patch, animal-derived
Hemagard Patch Knitted Collagen Coated Vascular Patch
INTERVASCULAR SAS
HGK10/140P (1)
In Commercial Distribution

  • 00384401014874 ()

  • Width: 10 Millimeter
  • Length: 140 Millimeter
HGK10/140P (1)

  • Cardiovascular patch, animal-derived
Hemagard Patch Knitted Collagen Coated Vascular Patch
INTERVASCULAR SAS
HGK100/100P (1)
In Commercial Distribution

  • 00384401014867 ()

  • Width: 100 Millimeter
  • Length: 100 Millimeter
HGK100/100P (1)

  • Cardiovascular patch, animal-derived
Hemagard Patch Knitted Collagen Coated Vascular Patch
INTERVASCULAR SAS
HGK75/75P (1)
In Commercial Distribution

  • 00384401014850 ()

  • Width: 75 Millimeter
  • Length: 75 Millimeter
HGK75/75P (1)

  • Cardiovascular patch, animal-derived
Hemagard Patch Knitted Collagen Coated Vascular Patch
INTERVASCULAR SAS
HGK50/50P (1)
In Commercial Distribution

  • 00384401014843 ()

  • Width: 50 Millimeter
  • Length: 50 Millimeter
HGK50/50P (1)

  • Cardiovascular patch, animal-derived
Hemagard Patch Knitted Collagen Coated Vascular Patch
INTERVASCULAR SAS
HGK25/100P (1)
In Commercial Distribution

  • 00384401014836 ()

  • Width: 25 Millimeter
  • Length: 100 Millimeter
HGK25/100P (1)

  • Cardiovascular patch, animal-derived
Hemagard Patch Knitted Collagen Coated Vascular Patch
INTERVASCULAR SAS
HGK25/50P (1)
In Commercial Distribution

  • 00384401014829 ()

  • Width: 25 Millimeter
  • Length: 50 Millimeter
HGK25/50P (1)

  • Cardiovascular patch, animal-derived
Hemacarotid Patch Knitted Ultrathin Collagen Coated Vascular Patch
INTERVASCULAR SAS
HEK25/100CPUT (1)
In Commercial Distribution

  • 00384401011248 ()

  • Length: 100 Millimeter
  • Width: 25 Millimeter
HEK25/100CPUT (1)

  • Cardiovascular patch, animal-derived
Hemacarotid Patch Knitted Ultrathin Collagen Coated Vascular Patch
INTERVASCULAR SAS
HEK10/150CPUT (1)
In Commercial Distribution

  • 00384401011224 ()

  • Length: 150 Millimeter
  • Width: 10 Millimeter
HEK10/150CPUT (1)

  • Cardiovascular patch, animal-derived
Digital Transmitter for the Avery Breathing Pacemaker System
Avery Biomedical Devices Inc
NeurostimulatorTransmitter Digital
In Commercial Distribution

  • 00850252006066 ()
Spirit

  • Extramuscular diaphragm/phrenic nerve electrical stimulation system
No Description
Avery Biomedical Devices Inc
Transtelephonic Monitor
Not in Commercial Distribution

  • 00850252006059 ()
TTM

  • Extramuscular diaphragm/phrenic nerve electrical stimulation system
(902A) 2.0 m Lead Length
Avery Biomedical Devices Inc
External Antenna
In Commercial Distribution

  • 00850252006042 ()
902AL

  • Extramuscular diaphragm/phrenic nerve electrical stimulation system
(902A) 1.0 m Lead Length
Avery Biomedical Devices Inc
External Antenna
In Commercial Distribution

  • 00850252006035 ()
902A

  • Extramuscular diaphragm/phrenic nerve electrical stimulation system
No Description
Avery Biomedical Devices Inc
Neurostimulator Electrode Implant
In Commercial Distribution

  • 00850252006028 ()
E377-05

  • Extramuscular diaphragm/phrenic nerve electrical stimulation system
No Description
Avery Biomedical Devices Inc
Neurostimulator Receiver Implant
In Commercial Distribution

  • 00850252006011 ()
I-110A

  • Extramuscular diaphragm/phrenic nerve electrical stimulation system
No Description
Avery Biomedical Devices Inc
Neurostimulator Transmitter
In Commercial Distribution

  • 00850252006004 ()
MARK IV

  • Extramuscular diaphragm/phrenic nerve electrical stimulation system
Refill Kit
Medos International Sàrl
91-4287
In Commercial Distribution

  • 10886704072072 ()
914287

  • Implantable intrathecal infusion pump, programmable
Refill Kit
Codman Neuro Sciences Sàrl
91-4285US
In Commercial Distribution

  • 20886704071454 ()
  • 10886704071457 ()
914285US

  • Implantable intrathecal infusion pump, programmable
Bolus Kit
Medos International Sàrl
91-4284US
In Commercial Distribution

  • 10886704071440 ()
914284US

  • Implantable intrathecal infusion pump, programmable
Refill Kit
Medos International Sàrl
91-4288
In Commercial Distribution

  • 20886704064951 ()
  • 10886704064954 ()
914288

  • Implantable intrathecal infusion pump, programmable
Prometra II 40ml Programmable Pump
Flowonix Medical, Inc.
16827
In Commercial Distribution

  • 00810335020242 ()


  • Implantable intrathecal infusion pump, programmable
The Prometra II Programmable Pump is a sterile, battery-operated, teardrop-shaped implantable, programmable infusion pump, with a rigid titanium housing and flow controller system, which dispenses infusate into the intrathecal space through an implanted intrathecal catheter. To help increase safety, the Prometra II Pump incorporates a safety valve (flow-activated valve or FAV) that will shut off drug flow to the patient in the event a high flow rate occurs, such as during an MRI. All functions of the system (e.g., dosing) are controlled externally using a hand-held, battery-operated programmer. The Prometra II Pump contains a metal bellows drug reservoir with a capacity of 20 milliliters (mL). The reservoir propellant is stored within the rigid housing surrounding the bellows and provides the driving pressure for the pump. The driving pressure on the reservoir forces the infusate through an outlet filter (0.22 pm), and into an electronically controlled flow metering valve-accumulator subsystem. The Infumorph passes from the flow metering subsystem, into the catheter access port then into the catheter for delivery to the intrathecal space.
Flowonix Medical, Inc.
13827
In Commercial Distribution

  • 00810335020228 ()


  • Implantable intrathecal infusion pump, programmable
The Prometra Programmable Pump is a sterile, battery-operated, teardrop-shaped implantable, programmable infusion pump, with a rigid titanium housing and flow controller system, which dispenses infusate into the intrathecal space through an implanted intrathecal catheter.
Flowonix Medical, Inc.
11827
In Commercial Distribution

  • 00810335020082 ()


  • Implantable intrathecal infusion pump, programmable
PUMP 8637-40 SM II 40ML EMAN SYMBL GRC
MEDTRONIC, INC.
8637-40
In Commercial Distribution

  • 00763000422615 ()


  • Implantable intrathecal infusion pump, programmable
PUMP 8637-20 SM II 20ML EMAN SYMBL GRC
MEDTRONIC, INC.
8637-20
In Commercial Distribution

  • 00763000422608 ()


  • Implantable intrathecal infusion pump, programmable
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