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.
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
VASCU-GUARD Peripheral Vascular Patch is prepared from bovine pericardium which is cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. VASCU-GUARD Peripheral Vascular Patch is chemically sterilized using ethanol and propylene oxide. VASCU-GUARD Peripheral Vascular Patch has been treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20 - 25°C. VASCU-GUARD Peripheral Vascular Patch is packaged in a container filled with sterile, non-pyrogenic water containing propylene oxide. The contents of the unopened, undamaged container are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
VG0209N
In Commercial Distribution

  • 00085412530925 ()
VG0209N

  • Cardiovascular patch, animal-derived
VASCU-GUARD Peripheral Vascular Patch is prepared from bovine pericardium which is cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. VASCU-GUARD Peripheral Vascular Patch is chemically sterilized using ethanol and propylene oxide. VASCU-GUARD Peripheral Vascular Patch has been treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20 - 25°C. VASCU-GUARD Peripheral Vascular Patch is packaged in a container filled with sterile, non-pyrogenic water containing propylene oxide. The contents of the unopened, undamaged container are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
VG0110N
In Commercial Distribution

  • 00085412530918 ()
VG0110N

  • Cardiovascular patch, animal-derived
VASCU-GUARD Peripheral Vascular Patch is prepared from bovine pericardium which is cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. VASCU-GUARD Peripheral Vascular Patch is chemically sterilized using ethanol and propylene oxide. VASCU-GUARD Peripheral Vascular Patch has been treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20 - 25°C. VASCU-GUARD Peripheral Vascular Patch is packaged in a container filled with sterile, non-pyrogenic water containing propylene oxide. The contents of the unopened, undamaged container are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
VG0108N
In Commercial Distribution

  • 00085412530895 ()
VG0108N

  • Cardiovascular patch, animal-derived
VASCU-GUARD Peripheral Vascular Patch is prepared from bovine pericardium which is cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. VASCU-GUARD Peripheral Vascular Patch is chemically sterilized using ethanol and propylene oxide. VASCU-GUARD Peripheral Vascular Patch has been treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20 - 25 C. VASCU-GUARD Peripheral Vascular Patch is packaged in a container filled with sterile, non-pyrogenic water containing propylene oxide. The contents of the unopened, undamaged container are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
VG0106N
In Commercial Distribution

  • 00085412530871 ()
VG0106N

  • Cardiovascular patch, animal-derived
SUPPLE PERI-GUARD Repair Patch is prepared from bovine pericardium cross-linked with glutaraldehyde. The tissue, procured from cattle originating in the USA is chemically sterilized using ethanol and propylene oxide, and treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25°C. SUPPLE PERI-GUARD is MR safe.
SYNOVIS LIFE TECHNOLOGIES, INC.
PC1016SN
In Commercial Distribution

  • 00085412530710 ()
PC1016SNBIO

  • Cardiovascular patch, animal-derived
SUPPLE PERI-GUARD Repair Patch is prepared from bovine pericardium cross-linked with glutaraldehyde. The tissue, procured from cattle originating in the USA is chemically sterilized using ethanol and propylene oxide, and treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25°C. SUPPLE PERI-GUARD is MR safe.
SYNOVIS LIFE TECHNOLOGIES, INC.
PC0814SN
In Commercial Distribution

  • 00085412530697 ()
PC0814SNBIO

  • Cardiovascular patch, animal-derived
SUPPLE PERI-GUARD Repair Patch is prepared from bovine pericardium cross-linked with glutaraldehyde. The tissue, procured from cattle originating in the USA is chemically sterilized using ethanol and propylene oxide, and treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25°C. SUPPLE PERI-GUARD is MR safe.
SYNOVIS LIFE TECHNOLOGIES, INC.
PC0608SN
In Commercial Distribution

  • 00085412530673 ()
PC0608SNBIO

  • Cardiovascular patch, animal-derived
SUPPLE PERI-GUARD Repair Patch is prepared from bovine pericardium cross-linked with glutaraldehyde. The tissue, procured from cattle originating in the USA is chemically sterilized using ethanol and propylene oxide, and treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25°C. SUPPLE PERI-GUARD is MR safe.
SYNOVIS LIFE TECHNOLOGIES, INC.
PC0404SN
In Commercial Distribution

  • 00085412530642 ()
PC0404SNBIO

  • Cardiovascular patch, animal-derived
Peri-Guard Repair Patch (Peri-Guard) is a biologic tissue prepared from bovine pericardium cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. Peri-Guard is chemically sterilized using ethanol and propylene oxide. Peri-Guard is treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25C.
SYNOVIS LIFE TECHNOLOGIES, INC.
PC1225N
In Commercial Distribution

  • 00085412530628 ()
PC1225NBIO

  • Cardiovascular patch, animal-derived
Peri-Guard Repair Patch (Peri-Guard) is a biologic tissue prepared from bovine pericardium cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. Peri-Guard is chemically sterilized using ethanol and propylene oxide. Peri-Guard is treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25C.
SYNOVIS LIFE TECHNOLOGIES, INC.
PC1016N
In Commercial Distribution

  • 00085412530604 ()
PC1016NBIO

  • Cardiovascular patch, animal-derived
Peri-Guard Repair Patch (Peri-Guard) is a biologic tissue prepared from bovine pericardium cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. Peri-Guard is chemically sterilized using ethanol and propylene oxide. Peri-Guard is treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25C.
SYNOVIS LIFE TECHNOLOGIES, INC.
PC0814N
In Commercial Distribution

  • 00085412530581 ()
PC0814NBIO

  • Cardiovascular patch, animal-derived
Peri-Guard Repair Patch (Peri-Guard) is a biologic tissue prepared from bovine pericardium cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. Peri-Guard is chemically sterilized using ethanol and propylene oxide. Peri-Guard is treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25C.
SYNOVIS LIFE TECHNOLOGIES, INC.
PC0608N
In Commercial Distribution

  • 00085412530567 ()
PC0608NBIO

  • 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 Transmitter
In Commercial Distribution

  • 00850252006004 ()
MARK IV

  • 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
Epicel (cultured epidermal autografts) is an aseptically processed wound dressing composed of the patient’s own (autologous) keratinocytes grown ex vivo in the presence of proliferation-arrested, murine (mouse) fibroblasts. Epicel consists of sheets of proliferative, autologous keratinocytes, ranging from 2 to 8 cell layers thick and is referred to as a cultured epidermal autograft. Each graft of Epicel is attached to petrolatum gauze backing with titanium surgical clips and measures a minimum of 50 cm2 in area. Epicel is authorized by Federal law for use in adult and pediatric patients who have deep dermal or full-thickness burns comprising a total body surface area greater than or equal to 30%. Epicel may be used in conjunction with split-thickness autografts, or alone in patients for whom split-thickness autografts may not be an option due to the severity and extent of their burns.
VERICEL CORPORATION
N/A
In Commercial Distribution

  • W41020AU201S1969 ()

  • Area/Surface Area: 50 Square centimeter


  • Cultured skin autograft/xenograft
Epicel (cultured epidermal autografts) is an aseptically processed wound dressing composed of the patient’s own (autologous) keratinocytes grown ex vivo in the presence of proliferation-arrested, murine (mouse) fibroblasts. Epicel consists of sheets of proliferative, autologous keratinocytes, ranging from 2 to 8 cell layers thick and is referred to as a cultured epidermal autograft. Each graft of Epicel is attached to petrolatum gauze backing with titanium surgical clips and measures approximately 50 cm2 in area. Epicel is authorized by Federal law for use in adult and pediatric patients who have deep dermal or full-thickness burns comprising a total body surface area greater than or equal to 30%. Epicel may be used in conjunction with split-thickness autografts, or alone in patients for whom split-thickness autografts may not be an option due to the severity and extent of their burns.
VERICEL CORPORATION
0
In Commercial Distribution

  • W41020AU201P0001 ()

  • Area/Surface Area: 50 Square centimeter


  • Cultured skin autograft/xenograft
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
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
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