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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SEEG DEPTH ELECTRODE, 3x5 CONTACTS, EXPLORATION LENGTH 70MM, Ø 0.8MM, LONG LENGTH
DIXI MEDICAL
MICRODEEP DEPTH ELECTRODE
In Commercial Distribution

  • 03664539000114 ()

  • Special Insulating Length between groups of 5 contacts 11 Millimeters
  • Contact Length 2 Millimeters
  • Contact Spacing 3.5 Millimeters
D08-15CM

  • Depth electrode
SEEG DEPTH ELECTRODE, 15 CONTACTS, EXPLORATION LENGTH 51MM, Ø 0.8MM, SHORT LENGTH
DIXI MEDICAL
MICRODEEP DEPTH ELECTRODE
Not in Commercial Distribution

  • 03664539000107 ()

  • Contact Spacing 3.5 Millimeters
  • Contact Length 2 Millimeters
D08-15AT

  • Depth electrode
SEEG DEPTH ELECTRODE, 15 CONTACTS, EXPLORATION LENGTH 51MM, Ø 0.8MM, LONG LENGTH
DIXI MEDICAL
MICRODEEP DEPTH ELECTRODE
In Commercial Distribution

  • 03664539000091 ()

  • Contact Length 2 Millimeters
  • Contact Spacing 3.5 Millimeters
D08-15AM

  • Depth electrode
SEEG DEPTH ELECTRODE, 12 CONTACTS, EXPLORATION LENGTH 40.5MM, Ø 0.8MM, SHORT LENGTH
DIXI MEDICAL
MICRODEEP DEPTH ELECTRODE
Not in Commercial Distribution

  • 03664539000084 ()

  • Contact Length 2 Millimeters
  • Contact Spacing 3.5 Millimeters
D08-12AT

  • Depth electrode
SEEG DEPTH ELECTRODE, 12 CONTACTS, EXPLORATION LENGTH 40.5MM, Ø 0.8MM, LONG LENGTH
DIXI MEDICAL
MICRODEEP DEPTH ELECTRODE
In Commercial Distribution

  • 03664539000077 ()

  • Contact Length 2 Millimeters
  • Contact Spacing 3.5 Millimeters
D08-12AM

  • Depth electrode
SEEG DEPTH ELECTRODE, 10 CONTACTS, EXPLORATION LENGTH 33.5MM, Ø 0.8MM, SHORT LENGTH
DIXI MEDICAL
MICRODEEP DEPTH ELECTRODE
Not in Commercial Distribution

  • 03664539000060 ()

  • Contact Length 2 Millimeters
  • Contact Spacing 3.5 Millimeters
D08-10AT

  • Depth electrode
SEEG DEPTH ELECTRODE, 10 CONTACTS, EXPLORATION LENGTH 33.5MM, Ø 0.8MM, LONG LENGTH
DIXI MEDICAL
MICRODEEP DEPTH ELECTRODE
In Commercial Distribution

  • 03664539000053 ()

  • Contact Length 2 Millimeters
  • Contact Spacing 3.5 Millimeters
D08-10AM

  • Depth electrode
SEEG DEPTH ELECTRODE, 8 CONTACTS, EXPLORATION LENGTH 26.5MM, Ø 0.8MM, SHORT LENGTH
DIXI MEDICAL
MICRODEEP DEPTH ELECTRODE
Not in Commercial Distribution

  • 03664539000046 ()

  • Contact Spacing 3.5 Millimeters
  • Contact Length 2 Millimeters
D08-08AT

  • Depth electrode
SEEG DEPTH ELECTRODE, 8 CONTACTS, EXPLORATION LENGTH 26.5MM, Ø 0.8MM, LONG LENGTH
DIXI MEDICAL
MICRODEEP DEPTH ELECTRODE
In Commercial Distribution

  • 03664539000039 ()

  • Contact Spacing 3.5 Millimeters
  • Contact Length 2 Millimeters
D08-08AM

  • Depth electrode
SEEG DEPTH ELECTRODE, 5 CONTACTS, EXPLORATION LENGTH 16MM, Ø 0.8MM, SHORT LENGTH
DIXI MEDICAL
MICRODEEP DEPTH ELECTRODE
Not in Commercial Distribution

  • 03664539000022 ()

  • Contact Spacing 3.5 Millimeters
  • Contact Length 2 Millimeters
D08-05AT

  • Depth electrode
SEEG DEPTH ELECTRODE, 5 CONTACTS, EXPLORATION LENGTH 16MM, Ø 0.8MM, LONG LENGTH
DIXI MEDICAL
MICRODEEP DEPTH ELECTRODE
In Commercial Distribution

  • 03664539000015 ()

  • Contact Spacing 3.5 Millimeters
  • Contact Length 2 Millimeters
D08-05AM

  • Depth electrode
No Description
Edwards Lifesciences LLC
4700
In Commercial Distribution

  • 00690103144178 ()

  • 10 CENTIMETERS WIDE BY 15 CENTIMETERS LONG. USER WILL TAILOR TO DESIRED SIZE.
4700

  • Cardiovascular patch, animal-derived
Bovine pericardial vascular patch
Edwards Lifesciences LLC
DP2X9
In Commercial Distribution

  • 00690103199048 ()

  • 2 CM X 9 CM
DP2X9

  • Cardiovascular patch, animal-derived
Bovine pericardial vascular patch
Edwards Lifesciences LLC
DP1X6
In Commercial Distribution

  • 00690103199031 ()

  • 1 CM X 6 CM
DP1X6

  • Cardiovascular patch, animal-derived
Bovine pericardial vascular patch
Edwards Lifesciences LLC
DP08X8
In Commercial Distribution

  • 00690103199024 ()

  • 0.8 CM X 8 CM
DP08X8

  • Cardiovascular patch, animal-derived
CryoTip
FUJIFILM IRVINE SCIENTIFIC, INC.
40709-Pack
In Commercial Distribution

  • 00893727002118 ()
  • 10893727002115 ()
40709

  • Assisted reproduction cryotube
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
Decellularized Bovine Pericardium
GENESEE BIOMEDICAL, INC.
PFP6x8
In Commercial Distribution

  • B040PFP6X81 ()
N/A

  • Cardiovascular patch, animal-derived
CardiaMend 1.0 Pericardial and Epicardial Reconstruction Matrix 7 x 15 cm
Helios Cardio Inc.
CMUS-10NS-0715
In Commercial Distribution

  • 00850023375070 ()

  • Width: 15 Centimeter
  • Height: 1.0 Millimeter
  • Length: 7 Centimeter
CMUS-10NS-0715

  • Cardiovascular patch, animal-derived
CardiaMend 0.5 Pericardial and Epicardial Reconstruction Matrix 4 x 7 cm
Helios Cardio Inc.
CMUS-05NS-0407
In Commercial Distribution

  • 00850023375056 ()

  • Length: 4 Centimeter
  • Width: 7 Centimeter
  • Height: 0.5 Millimeter
CMUS-05NS-0407

  • Cardiovascular patch, animal-derived
CardiaMend 0.5 Pericardial and Epicardial Reconstruction Matrix 5 x 6 cm
Helios Cardio Inc.
CMUS-05NS-0506
In Commercial Distribution

  • 00850023375087 ()

  • Length: 5 Centimeter
  • Width: 6 Centimeter
  • Height: 0.5 Millimeter
CMUS-05NS-0506

  • Cardiovascular patch, animal-derived
CardiaMend 1.0 Pericardial and Epicardial Reconstruction Matrix 8 x 12 cm
Helios Cardio Inc.
CMUS-10NS-0812
In Commercial Distribution

  • 00850023375063 ()

  • Length: 8 Centimeter
  • Width: 12 Centimeter
  • Height: 1.0 Millimeter
CMUS-10NS-0812

  • Cardiovascular patch, animal-derived
CardiaMend 0.5 Pericardial and Epicardial Reconstruction Matrix 8 x 12 cm
Helios Cardio Inc.
CMUS-05NS-0812
In Commercial Distribution

  • 00850023375049 ()

  • Length: 8 Centimeter
  • Width: 12 Centimeter
  • Height: 0.5 Millimeter
CMUS-05NS-0812

  • Cardiovascular patch, animal-derived
CardiaMend 1.0 Pericardial and Epicardial Reconstruction Matrix 10 x 15 cm
Helios Cardio Inc.
CMUS-10NS-1015
In Commercial Distribution

  • 00850023375032 ()

  • Length: 10 Centimeter
  • Width: 15 Centimeter
  • Height: 1 Millimeter
CMUS-10NS-1015

  • Cardiovascular patch, animal-derived
CardiaMend 1.0 Pericardial and Epicardial Reconstruction Matrix 5 x 6 cm
Helios Cardio Inc.
CMUS-10NS-0506
In Commercial Distribution

  • 00850023375025 ()

  • Length: 5 Centimeter
  • Width: 6 Centimeter
  • Height: 1 Millimeter
CMUS-10NS-0506

  • Cardiovascular patch, animal-derived
CardiaMend 1.0 Pericardial and Epicardial Reconstruction Matrix 8 x 16 cm
Helios Cardio Inc.
CMUS-10NS-0816
In Commercial Distribution

  • 00850023375018 ()

  • Length: 8 Centimeter
  • Width: 16 Centimeter
  • Height: 1 Millimeter
CMUS-10NS-0816

  • Cardiovascular patch, animal-derived
CardiaMend 1.0 Pericardial and Epicardial Reconstruction Matrix 6 x 12 cm
Helios Cardio Inc.
CMUS-10NS-0612
In Commercial Distribution

  • 00850023375001 ()

  • Length: 6 Centimeter
  • Width: 12 Centimeter
  • Height: 1 Millimeter
CMUS-10NS-0612

  • Cardiovascular patch, animal-derived
No Description
Hertart ApS
16106
In Commercial Distribution

  • 27350025914606 ()
  • 17350025914609 ()
  • 07350025914602 ()


  • Assisted reproduction centrifuge tube
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