Company Name Brand Name GMDN Term 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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Prometra II 40ml Programmable Pump
Flowonix Medical, Inc.
16827
In Commercial Distribution

  • 00810335020242 ()


  • 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
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
Premier Filter Pack for Premier Evacuator. Contains five disposable Premier filters.
DERMATOLOGIC LAB AND SUPPLY, INC.
9006290
In Commercial Distribution

  • D69190062901 ()
  • D69190062900 ()
9006290

  • Surgical plume evacuation system
Premier Evacuator 220V Air Filtration System. Contains one Premier Evacuator 220V unit, one detachable cord, and Disposable Filter Pack (5 filters - reorder number 9006290).
DERMATOLOGIC LAB AND SUPPLY, INC.
9006298
In Commercial Distribution

  • D69190062980 ()
9006298

  • Surgical plume evacuation system
Premier Evacuator 110V Air Filtration System. Contains one Premier Evacuator 110V unit, one detachable cord, and Disposable Filter Pack (5 filters - reorder number 9006290).
DERMATOLOGIC LAB AND SUPPLY, INC.
9006300
In Commercial Distribution

  • D69190063000 ()
9006300

  • Surgical plume evacuation system
Surgical Smoke Evacuator
Buffalo Filter
PPS604
In Commercial Distribution

  • 00851136002044 ()


  • Surgical plume evacuation system
Surgical Smoke Evacuator with Filter
Buffalo Filter
PSWTURBO AS
In Commercial Distribution

  • 00851136002419 ()


  • Surgical plume evacuation system
No Description
AD-TECH MEDICAL INSTRUMENT CORPORATION
FLANGE-X
In Commercial Distribution

  • 00841823103499 ()
FLANGE-X

  • Depth electrode
Decellularized Bovine Pericardium
Cryolife, Inc.
PFP2X9
In Commercial Distribution

  • 00877234000652 ()

  • Width: 2 Centimeter
  • Length: 9 Centimeter
PFP2X9

  • Cardiovascular patch, animal-derived
Decellularized Bovine Pericardium
Cryolife, Inc.
PFP1X14
In Commercial Distribution

  • 00877234000645 ()

  • Width: 1 Centimeter
  • Length: 14 Centimeter
PFP1X14

  • Cardiovascular patch, animal-derived
Decellularized Bovine Pericardium
Cryolife, Inc.
PFP1X10
In Commercial Distribution

  • 00877234000638 ()

  • Width: 1 Centimeter
  • Length: 10 Centimeter
PFP1X10

  • Cardiovascular patch, animal-derived
Decellularized Bovine Pericardium
Cryolife, Inc.
PFP4X4
In Commercial Distribution

  • 00877234000546 ()

  • Width: 4 Centimeter
  • Length: 4 Centimeter
PFP4X4

  • Cardiovascular patch, animal-derived
Decellularized Bovine Pericardium
Cryolife, Inc.
PFP6X8
In Commercial Distribution


  • Width: 6 Centimeter
  • Length: 8 Centimeter
PFP6X8

  • Cardiovascular patch, animal-derived
Decellularized Bovine Pericardium
Cryolife, Inc.
PFP8X14
In Commercial Distribution

  • 00877234000560 ()

  • Width: 8 Centimeter
  • Length: 14 Centimeter
PFP8X14

  • Cardiovascular patch, animal-derived
Decellularized Bovine Pericardium
Cryolife, Inc.
PFP0.8X8
In Commercial Distribution

  • 00877234000553 ()

  • Width: 0.8 Centimeter
  • Length: 8 Centimeter
PFP0.8X8

  • Cardiovascular patch, animal-derived
Decellularized Bovine Pericardium
Cryolife, Inc.
PFP1X6
In Commercial Distribution

  • 00877234000539 ()

  • Width: 1 Centimeter
  • Length: 6 Centimeter
PFP1X6

  • Cardiovascular patch, animal-derived
Decellularized Bovine Pericardium
Cryolife, Inc.
PFP 6x8
In Commercial Distribution


  • Width: 6 Centimeter
  • Length: 8 Centimeter
PFP 6x8

  • Cardiovascular patch, animal-derived
Decellularized Bovine Pericardium
GENESEE BIOMEDICAL, INC.
PFP6x8
In Commercial Distribution

  • B040PFP6X81 ()
N/A

  • Cardiovascular patch, animal-derived
Origin Stem, Coxa Vara Size 18
PAXEON RECONSTRUCTION LLC
PR111-18-1804
In Commercial Distribution

  • 08177570200696 ()


  • Coated hip femur prosthesis, modular
Origin Stem, Coxa Vara Size 16
PAXEON RECONSTRUCTION LLC
PR111-18-1604
In Commercial Distribution

  • 08177570200658 ()


  • Coated hip femur prosthesis, modular
Origin Stem, Coxa Vara Size 15
PAXEON RECONSTRUCTION LLC
PR111-18-1504
In Commercial Distribution

  • 08177570200610 ()


  • Coated hip femur prosthesis, modular
Origin Stem, Coxa Vara Size 14
PAXEON RECONSTRUCTION LLC
PR111-18-1404
In Commercial Distribution

  • 08177570200573 ()


  • Coated hip femur prosthesis, modular
Origin Stem, Coxa Vara Size 13
PAXEON RECONSTRUCTION LLC
PR111-18-1304
In Commercial Distribution

  • 08177570200535 ()


  • Coated hip femur prosthesis, modular
Origin Stem, Coxa Vara Size 12
PAXEON RECONSTRUCTION LLC
PR111-18-1204
In Commercial Distribution

  • 08177570200498 ()


  • Coated hip femur prosthesis, modular
Origin Stem, Coxa Vara Size 11
PAXEON RECONSTRUCTION LLC
PR111-18-1104
In Commercial Distribution

  • 08177570200450 ()


  • Coated hip femur prosthesis, modular
Origin Stem, Coxa Vara Size 10
PAXEON RECONSTRUCTION LLC
PR111-18-1004
In Commercial Distribution

  • 08177570200412 ()


  • Coated hip femur prosthesis, modular
Origin Stem, Coxa Vara Size 9
PAXEON RECONSTRUCTION LLC
PR111-18-0904
In Commercial Distribution

  • 08177570200375 ()


  • Coated hip femur prosthesis, modular
No Description
PAXEON RECONSTRUCTION LLC
Origin Stem Lateral Offset Collared Size 18
In Commercial Distribution

  • 08177570205059 ()
PR111-18-1803

  • Coated femoral stem prosthesis, modular
No Description
PAXEON RECONSTRUCTION LLC
Origin Stem Lateral Offset Collared Size 16
In Commercial Distribution

  • 08177570205042 ()
PR111-18-1603

  • Coated femoral stem prosthesis, modular
No Description
PAXEON RECONSTRUCTION LLC
Origin Stem Lateral Offset Collared Size 15
In Commercial Distribution

  • 08177570205035 ()
PR111-18-1503

  • Coated femoral stem prosthesis, modular
No Description
PAXEON RECONSTRUCTION LLC
Origin Stem Lateral Offset Collared Size 14
In Commercial Distribution

  • 08177570205028 ()
PR111-18-1403

  • Coated femoral stem prosthesis, modular
No Description
PAXEON RECONSTRUCTION LLC
Origin Stem Lateral Offset Collared Size 13
In Commercial Distribution

  • 08177570205011 ()
PR111-18-1303

  • Coated femoral stem prosthesis, modular
No Description
PAXEON RECONSTRUCTION LLC
Origin Stem Lateral Offset Collared Size 12
In Commercial Distribution

  • 08177570205004 ()
PR111-18-1203

  • Coated femoral stem prosthesis, modular
No Description
PAXEON RECONSTRUCTION LLC
Origin Stem Lateral Offset Collared Size 11
In Commercial Distribution

  • 08177570204991 ()
PR111-18-1103

  • Coated femoral stem prosthesis, modular
No Description
PAXEON RECONSTRUCTION LLC
Origin Stem Lateral Offset Collared Size 10
In Commercial Distribution

  • 08177570204984 ()
PR111-18-1003

  • Coated femoral stem prosthesis, modular
No Description
PAXEON RECONSTRUCTION LLC
Origin Stem Lateral Offset Collared Size 9
In Commercial Distribution

  • 08177570204977 ()
PR111-18-0903

  • Coated femoral stem prosthesis, modular
No Description
PAXEON RECONSTRUCTION LLC
Origin Stem Lateral Offset Collared Size 8
In Commercial Distribution

  • 08177570204960 ()
PR111-18-0803

  • Coated femoral stem prosthesis, modular
Origin Stem, Standard Offset Size 18 Collared
PAXEON RECONSTRUCTION LLC
PR111-18-1802
In Commercial Distribution

  • 08177570200689 ()


  • Coated hip femur prosthesis, modular
Origin Stem, High Offset Size 18
PAXEON RECONSTRUCTION LLC
PR111-18-1801
In Commercial Distribution

  • 08177570200672 ()


  • Coated hip femur prosthesis, modular
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