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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XenoSure Biologic Patch, 0.8cm x 8cm, eIFU
Lemaitre Vascular, Inc.
e0.8P8
In Commercial Distribution

  • 00840663106295 ()
e0.8P8

  • Cardiovascular patch, animal-derived
XenoSure Biologic Patch, 1cm x 6cm
Lemaitre Vascular, Inc.
e1P6
In Commercial Distribution

  • 00840663106288 ()
e1P6

  • Cardiovascular patch, animal-derived
XenoSure Biologic Patch, 1cmx10cm
Lemaitre Vascular, Inc.
1BV10
In Commercial Distribution

  • 00840663106097 ()


  • Cardiovascular patch, animal-derived
AlboSure Vascular Patch 2x9 cm
Lemaitre Vascular, Inc.
AP20090R
In Commercial Distribution

  • 00840663105021 ()
AP20090R

  • Cardiovascular patch, animal-derived
AlboSure Vascular Patch 1x 15 cm
Lemaitre Vascular, Inc.
AP10150R
In Commercial Distribution

  • 00840663104895 ()
AP10150R

  • Cardiovascular patch, animal-derived
AlboSure Vascular Patch 1x 10 cm
Lemaitre Vascular, Inc.
AP10100R
In Commercial Distribution

  • 00840663104802 ()
AP10100R

  • Cardiovascular patch, animal-derived
AlboSure Vascular Patch 1x 7.5 cm
Lemaitre Vascular, Inc.
AP10075T
In Commercial Distribution

  • 00840663104765 ()
AP10075T

  • Cardiovascular patch, animal-derived
AlboSure Vascular Patch 0.8x 7.5 cm
Lemaitre Vascular, Inc.
AP08075T
In Commercial Distribution

  • 00840663104604 ()
AP08075T

  • Cardiovascular patch, animal-derived
AlboSure Vascular Patch 0.6x 7.5 cm
Lemaitre Vascular, Inc.
AP06075T
In Commercial Distribution

  • 00840663104543 ()
AP06075T

  • Cardiovascular patch, animal-derived
The BioEnvelope is intended to securely hold a cardiac implantable electronic device to create a stable environment when implanted in the body. The cardiac implantable devices that may be used with the BioEnvelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices.
AZIYO BIOLOGICS, INC.
440579
In Commercial Distribution

  • 04035479160647 ()
  • 04035479160555 ()

  • SubQ


  • Cardiovascular patch, animal-derived
The BioEnvelope is intended to securely hold a cardiac implantable electronic device to create a stable environment when implanted in the body. The cardiac implantable devices that may be used with the BioEnvelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices.
AZIYO BIOLOGICS, INC.
440578
In Commercial Distribution

  • 04035479160548 ()
  • 04035479160654 ()

  • Width: 9.5 Centimeter
  • Height: 6.9 Centimeter


  • Cardiovascular patch, animal-derived
The BioEnvelope is intended to securely hold a cardiac implantable electronic device to create a stable environment when implanted in the body. The cardiac implantable devices that may be used with the BioEnvelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices.
AZIYO BIOLOGICS, INC.
440577
In Commercial Distribution

  • 04035479160531 ()
  • 04035479160616 ()

  • Width: 8.0 Centimeter
  • Height: 6.9 Centimeter


  • Cardiovascular patch, animal-derived
The BioEnvelope is intended to securely hold a cardiac implantable electronic device to create a stable environment when implanted in the body. The cardiac implantable devices that may be used with the BioEnvelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices.
AZIYO BIOLOGICS, INC.
440576
In Commercial Distribution

  • 04035479160524 ()
  • 04035479160623 ()

  • Width: 6.5 Centimeter
  • Height: 6.9 Centimeter


  • Cardiovascular patch, animal-derived
The BioEnvelope is intended to securely hold a cardiac implantable electronic device to create a stable environment when implanted in the body. The cardiac implantable devices that may be used with the BioEnvelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices.
AZIYO BIOLOGICS, INC.
440575
In Commercial Distribution

  • 04035479160517 ()
  • 04035479160630 ()


  • 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
(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
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
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
PUMP 8667-40 SYNCHROMEDIII INFUSION EMAN
MEDTRONIC, INC.
8667-40
In Commercial Distribution

  • 00763000597030 ()

  • Reservoir Volume 40 mL


  • Implantable intrathecal infusion pump, programmable
PUMP 8667-20 SYNCHROMEDIII INFUSION EMAN
MEDTRONIC, INC.
8667-20
In Commercial Distribution

  • 00763000597023 ()

  • Reservoir Volume 20 mL


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

  • 00763000634100 ()

  • Reservoir Volume 40 ML


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

  • 00763000634094 ()

  • Reservoir Volume 20 ML


  • Implantable intrathecal infusion pump, programmable
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
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