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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Hemapatch Knitted Collagen Coated Vascular Patch
INTERVASCULAR SAS
HEK25/100P (1)
In Commercial Distribution

  • 00384401001591 ()

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

  • Cardiovascular patch, animal-derived
Hemapatch Knitted Collagen Coated Vascular Patch
INTERVASCULAR SAS
HEK50/50P (1)
In Commercial Distribution

  • 00384401001577 ()

  • Length: 50 Millimeter
  • Width: 50 Millimeter
HEK50/50P (1)

  • Cardiovascular patch, animal-derived
Hemapatch Knitted Collagen Coated Vascular Patch
INTERVASCULAR SAS
HEK25/50P (1)
In Commercial Distribution

  • 00384401001560 ()

  • Length: 50 Millimeter
  • Width: 25 Millimeter
HEK25/50P (1)

  • Cardiovascular patch, animal-derived
Hemapatch Knitted Collagen Coated Vascular Patch
INTERVASCULAR SAS
HEK100/100P (1)
In Commercial Distribution

  • 00384401001522 ()

  • Length: 100 Millimeter
  • Width: 100 Millimeter
HEK100/100P (1)

  • Cardiovascular patch, animal-derived
Hemapatch Knitted Collagen Coated Vascular Patch
INTERVASCULAR SAS
HEK75/75P (1)
In Commercial Distribution

  • 00384401001515 ()

  • Length: 75 Millimeter
  • Width: 75 Millimeter
HEK75/75P (1)

  • Cardiovascular patch, animal-derived
Hemacarotidpatch Knitted Ultrathin Collagen Coated Vascular Patch
INTERVASCULAR SAS
HEK14/75CPUT (1)
In Commercial Distribution

  • 00384401001508 ()

  • Width: 14 Millimeter
  • Length: 75 Micrometer
HEK14/75CPUT (1)

  • Cardiovascular patch, animal-derived
Hemacarotidpatch Knitted Ultrathin Collagen Coated Vascular Patch
INTERVASCULAR SAS
HEK12/75CPUT (1)
In Commercial Distribution

  • 00384401001492 ()

  • Width: 12 Millimeter
  • Length: 75 Millimeter
HEK12/75CPUT (1)

  • Cardiovascular patch, animal-derived
Hemacarotidpatch Knitted Ultrathin Collagen Coated Vascular Patch
INTERVASCULAR SAS
HEK10/75CPUT (1)
In Commercial Distribution

  • 00384401001485 ()

  • Width: 10 Millimeter
  • Length: 75 Millimeter
HEK10/75CPUT (1)

  • Cardiovascular patch, animal-derived
Hemacarotidpatch Knitted Ultrathin Collagen Coated Vascular Patch
INTERVASCULAR SAS
HEK08/75CPUT (1)
In Commercial Distribution

  • 00384401001478 ()

  • Width: 8 Millimeter
  • Length: 75 Millimeter
HEK08/75CPUT (1)

  • Cardiovascular patch, animal-derived
Hemacarotidpatch Knitted Ultrathin Collagen Coated Vascular Patch
INTERVASCULAR SAS
HEK06/75CPUT (1)
In Commercial Distribution

  • 00384401001461 ()

  • Width: 6 Millimeter
  • Length: 75 Millimeter
HEK06/75CPUT (1)

  • Cardiovascular patch, animal-derived
Hemacarotidpatch Knitted Collagen Coated Vascular Patch
INTERVASCULAR SAS
HEK14/75CP (1)
In Commercial Distribution

  • 00384401001454 ()

  • Length: 75 Millimeter
  • Width: 14 Millimeter
HEK14/75CP (1)

  • Cardiovascular patch, animal-derived
Hemacarotidpatch Knitted Collagen Coated Vascular Patch
INTERVASCULAR SAS
HEK12/75CP (1)
In Commercial Distribution

  • 00384401001447 ()

  • Length: 75 Millimeter
  • Width: 12 Millimeter
HEK12/75CP (1)

  • Cardiovascular patch, animal-derived
Hemacarotidpatch Knitted Collagen Coated Vascular Patch
INTERVASCULAR SAS
HEK10/75CP (1)
In Commercial Distribution

  • 00384401001430 ()

  • Length: 75 Millimeter
  • Width: 10 Millimeter
HEK10/75CP (1)

  • Cardiovascular patch, animal-derived
Hemacarotidpatch Knitted Collagen Coated Vascular Patch
INTERVASCULAR SAS
HEK06/75CP (1)
In Commercial Distribution

  • 00384401001423 ()

  • Length: 75 Millimeter
  • Width: 6 Millimeter
HEK06/75CP (1)

  • Cardiovascular patch, animal-derived
Hemacarotidpatch Knitted Collagen Coated Vascular Patch
INTERVASCULAR SAS
HEK08/75CP (1)
In Commercial Distribution

  • 00384401001416 ()

  • Length: 75 Millimeter
  • Width: 8 Millimeter
HEK08/75CP (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
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
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
PUMP 8637-40 SM II 40ML EMAN SYMBL GRC
MEDTRONIC, INC.
8637-40
In Commercial Distribution

  • 00763000422615 ()


  • Implantable intrathecal infusion pump, programmable
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