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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PERI-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25 degrees C. PERI-GUARD is terminally sterilized using gamma irradiation and packaged within a double-pouch system. The contents of the unopened, undamaged outer pouch are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
PG1225
In Commercial Distribution

  • 00085412818658 ()
PG1225

  • Cardiovascular patch, animal-derived
VASCU-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25 degrees C. VASCU-GUARD is terminally sterilized using gamma irradiation. and packaged within a double-pouch system. The contents of the unopened, undamaged outer pouch are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
VG02515
In Commercial Distribution

  • 00085412818634 ()
VG02515

  • Cardiovascular patch, animal-derived
PERI-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25 degrees C. PERI-GUARD is terminally sterilized using gamma irradiation and packaged within a double-pouch system. The contents of the unopened, undamaged outer pouch are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
PG1016
In Commercial Distribution

  • 00085412818610 ()
PG1016

  • Cardiovascular patch, animal-derived
PERI-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25 degrees C. PERI-GUARD is terminally sterilized using gamma irradiation and packaged within a double-pouch system. The contents of the unopened, undamaged outer pouch are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
PG0814
In Commercial Distribution

  • 00085412818597 ()
PG0814

  • Cardiovascular patch, animal-derived
VASCU-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25 degrees C. VASCU-GUARD is terminally sterilized using gamma irradiation. and packaged within a double-pouch system. The contents of the unopened, undamaged outer pouch are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
VG0209
In Commercial Distribution

  • 00085412818573 ()
VG0209

  • Cardiovascular patch, animal-derived
VASCU-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25 degrees C. VASCU-GUARD is terminally sterilized using gamma irradiation. and packaged within a double-pouch system. The contents of the unopened, undamaged outer pouch are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
VG01510
In Commercial Distribution

  • 00085412818559 ()
VG01510

  • Cardiovascular patch, animal-derived
VASCU-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25 degrees C. VASCU-GUARD is terminally sterilized using gamma irradiation. and packaged within a double-pouch system. The contents of the unopened, undamaged outer pouch are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
VG0114
In Commercial Distribution

  • 00085412818535 ()
VG0114

  • Cardiovascular patch, animal-derived
VASCU-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25 degrees C. VASCU-GUARD is terminally sterilized using gamma irradiation. and packaged within a double-pouch system. The contents of the unopened, undamaged outer pouch are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
VG0110
In Commercial Distribution

  • 00085412818511 ()
VG0110

  • Cardiovascular patch, animal-derived
VASCU-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25 degrees C. VASCU-GUARD is terminally sterilized using gamma irradiation. and packaged within a double-pouch system. The contents of the unopened, undamaged outer pouch are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
VG0108
In Commercial Distribution

  • 00085412818498 ()
VG0108

  • Cardiovascular patch, animal-derived
VASCU-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25 degrees C. VASCU-GUARD is terminally sterilized using gamma irradiation. and packaged within a double-pouch system. The contents of the unopened, undamaged outer pouch are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
VG0106
In Commercial Distribution

  • 00085412818474 ()
VG0106

  • Cardiovascular patch, animal-derived
PERI-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25 degrees C. PERI-GUARD is terminally sterilized using gamma irradiation and packaged within a double-pouch system. The contents of the unopened, undamaged outer pouch are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
PG0608
In Commercial Distribution

  • 00085412818443 ()
PG0608

  • Cardiovascular patch, animal-derived
SUPPLE PERI-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25 degrees C. SUPPLE PERI-GUARD is terminally sterilized using gamma irradiation and packaged within a double-pouch system. The contents of the unopened, undamaged outer pouch are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
SPG1016
In Commercial Distribution

  • 00085412818429 ()
SPG1016

  • Cardiovascular patch, animal-derived
PERI-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25 degrees C. PERI-GUARD is terminally sterilized using gamma irradiation and packaged within a double-pouch system. The contents of the unopened, undamaged outer pouch are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
PG0404
In Commercial Distribution

  • 00085412818405 ()
PG0404

  • Cardiovascular patch, animal-derived
SUPPLE PERI-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25 degrees C. SUPPLE PERI-GUARD is terminally sterilized using gamma irradiation and packaged within a double-pouch system. The contents of the unopened, undamaged outer pouch are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
SPG0814
In Commercial Distribution

  • 00085412818375 ()
SPG0814

  • Cardiovascular patch, animal-derived
SUPPLE PERI-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25 degrees C. SUPPLE PERI-GUARD is terminally sterilized using gamma irradiation and packaged within a double-pouch system. The contents of the unopened, undamaged outer pouch are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
SPG0608
In Commercial Distribution

  • 00085412818313 ()
SPG0608

  • 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.
Elutia Med LLC
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.
Elutia Med LLC
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.
Elutia Med LLC
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.
Elutia Med LLC
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.
Elutia Med LLC
440575
In Commercial Distribution

  • 04035479160517 ()
  • 04035479160630 ()


  • Cardiovascular patch, animal-derived
The EluPro Antibiotic-Eluting BioEnvelope is a sterile pouch designed to hold a cardiac implantable device or implantable neurostimulator device to create a stable environment when implanted in the body. EluPro consists of decellularized, non-crosslinked, lyophilized extracellular matrix (ECM) and resorbable, ring- shaped poly(D,L Lactide-Co-Glycolide) (PLGA) discs containing the antibiotics rifampin and minocycline. The ECM material is derived from porcine small intestinal submucosa (SIS). The envelope is constructed with four multilaminate sheets, perforated to allow for the natural flow of exudate through the device. The drug-eluting polymer discs are secured between the multilaminate sheets on each side and the envelope is constructed with 5-0 polydioxanone (PDS) suture. EluPro contains 10.5 mg of rifampin and 9.3 mg of minocycline.
Elutia Med LLC
CMCV-124-LRG
In Commercial Distribution

  • 00859389005348 ()
  • 10859389005345 ()

  • Large


  • Cardiovascular patch, animal-derived
The EluPro Antibiotic-Eluting BioEnvelope is a sterile pouch designed to hold a cardiac implantable device or implantable neurostimulator device to create a stable environment when implanted in the body. EluPro consists of decellularized, non-crosslinked, lyophilized extracellular matrix (ECM) and resorbable, ring- shaped poly(D,L Lactide-Co-Glycolide) (PLGA) discs containing the antibiotics rifampin and minocycline. The ECM material is derived from porcine small intestinal submucosa (SIS). The envelope is constructed with four multilaminate sheets, perforated to allow for the natural flow of exudate through the device. The drug-eluting polymer discs are secured between the multilaminate sheets on each side and the envelope is constructed with 5-0 polydioxanone (PDS) suture. EluPro contains 10.5 mg of rifampin and 9.3 mg of minocycline.
Elutia Med LLC
CMCV-124-MED
In Commercial Distribution

  • 00859389005331 ()
  • 10859389005338 ()

  • Medium


  • Cardiovascular patch, animal-derived
VasCure for Vascular Repair is intended for use as a patch material for repair and reconstruction of peripheral vasculature including the carotid, renal, iliac, femoral, and tibial blood vessels. VasCure for Vascular Repair may be used for patch closure of vessels, as a pledget, or for suture line buttressing when repairing peripheral vessels.
Elutia Med LLC
CMCV-013-609
In Commercial Distribution

  • 10859389005147 ()
  • 00859389005140 ()

  • Height: 1 Centimeter
  • Width: 10 Centimeter


  • Cardiovascular patch, animal-derived
VasCure for Vascular Repair is intended for use as a patch material for repair and reconstruction of peripheral vasculature including the carotid, renal, iliac, femoral, and tibial blood vessels. VasCure for Vascular Repair may be used for patch closure of vessels, as a pledget, or for suture line buttressing when repairing peripheral vessels.
Elutia Med LLC
CMCV-011-606
In Commercial Distribution

  • 10859389005123 ()
  • 00859389005126 ()

  • Height: 2 Centimeter
  • Width: 10 Centimeter


  • Cardiovascular patch, animal-derived
The CanGaroo® Envelope is intended to securely hold a cardiac implantable electronic device or an implantable neurostimulator to create a stable environment when implanted in the body. The cardiac implantable electronic devices that may be used with the CanGaroo® Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices. The implantable neurostimulator devices that may be used with the CanGaroo® Envelope include vagus nerve stimulators, spinal cord neuromodulators, deep brain stimulators and sacral nerve stimulators.
Elutia Med LLC
CMCV-009-XXL
In Commercial Distribution

  • 10859389005116 ()
  • 00859389005119 ()

  • SubQ


  • Cardiovascular patch, animal-derived
Tyke is intended for use in neonates and infants for repair of pericardial structures, as an epicardial covering for damaged or repaired cardiac structures, as a patch material for intracardiac defects, septal defect and annulus repair, suture-line buttressing, and cardiac repair.
Elutia Med LLC
CMCV-098-204
In Commercial Distribution

  • 10859389005109 ()
  • 00859389005102 ()

  • Height: 4 Centimeter
  • Width: 7 Centimeter


  • Cardiovascular patch, animal-derived
VasCure for Carotid Repair is indicated for use as a patch material for vascular reconstruction and repair of the carotid artery, including patch closure following carotid endarterectomy and suture-line buttressing.
Elutia Med LLC
CMCV-073-609
In Commercial Distribution

  • 10859389005093 ()
  • 00859389005096 ()

  • Height: 1 Centimeter
  • Width: 10 Centimeter


  • Cardiovascular patch, animal-derived
VasCure for Carotid Repair is indicated for use as a patch material for vascular reconstruction and repair of the carotid artery, including patch closure following carotid endarterectomy and suture-line buttressing.
Elutia Med LLC
CMCV-072-606
In Commercial Distribution

  • 10859389005086 ()
  • 00859389005089 ()

  • Width: 10 Centimeter
  • Height: 2 Centimeter


  • Cardiovascular patch, animal-derived
The CanGaroo® Envelope is intended to securely hold a cardiac implantable electronic device or an implantable neurostimulator to create a stable environment when implanted in the body. The cardiac implantable electronic devices that may be used with the CanGaroo® Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices. The implantable neurostimulator devices that may be used with the CanGaroo® Envelope include vagus nerve stimulators, spinal cord neuromodulators, deep brain stimulators and sacral nerve stimulators.
Elutia Med LLC
CMCV-009-XLG
In Commercial Distribution

  • 10859389005079 ()
  • 00859389005072 ()

  • Extra Large


  • Cardiovascular patch, animal-derived
The CanGaroo® Envelope is intended to securely hold a cardiac implantable electronic device or an implantable neurostimulator to create a stable environment when implanted in the body. The cardiac implantable electronic devices that may be used with the CanGaroo® Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices. The implantable neurostimulator devices that may be used with the CanGaroo® Envelope include vagus nerve stimulators, spinal cord neuromodulators, deep brain stimulators and sacral nerve stimulators.
Elutia Med LLC
CMCV-009-LRG
In Commercial Distribution

  • 10859389005062 ()
  • 00859389005065 ()

  • Large


  • Cardiovascular patch, animal-derived
ProxiCor for Cardiac Tissue Repair is indicated for use as an intracardiac patch or pledget for tissue repair and suture-line buttressing.
Elutia Med LLC
CMCV-067-404
In Commercial Distribution

  • 10859389005055 ()
  • 00859389005058 ()

  • Width: 7 Centimeter
  • Height: 4 Centimeter


  • Cardiovascular patch, animal-derived
ProxiCor for Cardiac Tissue Repair is indicated for use as an intracardiac patch or pledget for tissue repair and suture-line buttressing.
Elutia Med LLC
CMCV-064-401
In Commercial Distribution

  • 10859389005048 ()
  • 00859389005041 ()

  • Width: 7 Centimeter
  • Height: 10 Centimeter


  • Cardiovascular patch, animal-derived
The CanGaroo® Envelope is intended to securely hold a cardiac implantable electronic device or an implantable neurostimulator to create a stable environment when implanted in the body. The cardiac implantable electronic devices that may be used with the CanGaroo® Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices. The implantable neurostimulator devices that may be used with the CanGaroo® Envelope include vagus nerve stimulators, spinal cord neuromodulators, deep brain stimulators and sacral nerve stimulators.
Elutia Med LLC
CMCV-009-MED
In Commercial Distribution

  • 10859389005031 ()
  • 00859389005034 ()

  • Medium


  • Cardiovascular patch, animal-derived
The CanGaroo® Envelope is intended to securely hold a cardiac implantable electronic device or an implantable neurostimulator to create a stable environment when implanted in the body. The cardiac implantable electronic devices that may be used with the CanGaroo® Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices. The implantable neurostimulator devices that may be used with the CanGaroo® Envelope include vagus nerve stimulators, spinal cord neuromodulators, deep brain stimulators and sacral nerve stimulators.
Elutia Med LLC
CMCV-009-SML
In Commercial Distribution

  • 10859389005024 ()
  • 00859389005027 ()

  • Small


  • Cardiovascular patch, animal-derived
ProxiCor for Pericardial Closure is a decellularized natural scaffold for repairing the pericardium following cardiac surgery.
Elutia Med LLC
CMCV-060-402
In Commercial Distribution

  • 10859389005017 ()
  • 00859389005010 ()

  • Width: 7.0 Centimeter
  • Height: 15.0 Centimeter


  • Cardiovascular patch, animal-derived
ProxiCor for Pericardial Closure is a decellularized natural scaffold for repairing the pericardium following cardiac surgery.
Elutia Med LLC
CMCV-059-401
In Commercial Distribution

  • 00859389005003 ()
  • 10859389005000 ()

  • Height: 10 Centimeter
  • Width: 7 Centimeter


  • 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 Transmitter
In Commercial Distribution

  • 00850252006004 ()
MARK IV

  • Extramuscular diaphragm/phrenic nerve electrical stimulation system
Queen's Square Bladder Stimulator (PC9)
MALEM MEDICAL LIMITED
PC9
In Commercial Distribution

  • 05060049630199 ()


  • Bladder-emptying vibratory stimulator
Queen's Square Bladder Stimulator - Selectable (PC9S)
MALEM MEDICAL LIMITED
PC9S
In Commercial Distribution

  • 05060049630144 ()


  • Bladder-emptying vibratory stimulator
Powered walking assistance device
B-Temia Inc
5062601
In Commercial Distribution

  • 07540162060007 ()


  • Programmable ambulation exoskeleton, clinical
Powered Exoskeleton - rehabilitation institution use
REWALK ROBOTICS LTD
50-30-0001
In Commercial Distribution

  • 00861803000327 ()


  • Programmable ambulation exoskeleton, clinical
Indego Therapy is a computerized, adjustable-fit powered exoskeleton, designed to restore walking function for impaired individuals.
Ekso Bionics, Inc.
501-110-001
In Commercial Distribution

  • M704501110001 ()


  • Programmable ambulation exoskeleton, clinical
Indego is a computerized, powered exoskeleton, designed to restore walking function for impaired individuals.
Ekso Bionics, Inc.
501-100-000
In Commercial Distribution

  • M704501100000 ()


  • Programmable ambulation exoskeleton, clinical
The device is a lightweight, wearable, battery-powered soft orthotic exosuit intended to be used to preform ambulatory functions in rehabilitation institutions under the supervision of a trained therapist for people with hemiplegia / hemiparesis due to stroke.
REWALK ROBOTICS LTD
50-40-0001
In Commercial Distribution

  • 00860001744507 ()


  • Programmable ambulation exoskeleton, clinical
Trexo Robotics XL Trexo Plus 1 Shipment
Trexo Robotics Inc.
A0001
In Commercial Distribution

  • 00628719321072 ()

  • XL
A001BPX

  • Programmable ambulation exoskeleton, clinical
Trexo Robotics Large Trexo Plus 1 Shipment
Trexo Robotics Inc.
A0001
In Commercial Distribution

  • 00628719321065 ()

  • Large
A001BPR

  • Programmable ambulation exoskeleton, clinical
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