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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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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
BAR300/BZO300/BUP10/COC150/MET500/MTD300/OPI2000/OXY100/TCA1000//THC50/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARDA10141 ()
  • B115ABCARDA10140 ()
ABCardA-10-14

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
BAR300/BZO300/BUP10/COC150/MET500/MTD300/OPI2000/OXY100/TCA1000//THC50
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARD10141 ()
  • B115ABCARD10140 ()
ABCard-10-14

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
INTEGRA Dermal Regeneration Template 8in. x 10in. (20cm x 25cm) is a bilayer membrane system for skin replacement. The dermal replacement layer is made of a porous matrix of fibers of cross-linked bovine tendon collagen and a glycosaminoglycan (chondroitin-6-sulfate) that is manufactured with a controlled porosity and defined degradation rate. The epidermal substitute layer is made of a thin polysiloxane (silicone) layer to control moisture loss from the wound.
Integra Lifesciences Corporation
38105
In Commercial Distribution

  • M269381051 ()
  • 10381780000617 ()
  • 00381780000610 ()

  • 8 in x 10 in
38105

  • Collagen wound matrix dressing
Integra® Dermal Regeneration Template 8in. x 10in. (20cm x 25cm)
Integra Lifesciences Corporation
38101
In Commercial Distribution

  • M269381011 ()
  • 10381780000600 ()

  • 8 in x 10 in
38101

  • Collagen wound matrix dressing
INTEGRA Dermal Regeneration Template 4in. x 10in. (10cm x 25cm) is a bilayer membrane system for skin replacement. The dermal replacement layer is made of a porous matrix of fibers of cross-linked bovine tendon collagen and a glycosaminoglycan (chondroitin-6-sulfate) that is manufactured with a controlled porosity and defined degradation rate. The epidermal substitute layer is made of a thin polysiloxane (silicone) layer to control moisture loss from the wound.
Integra Lifesciences Corporation
34105
In Commercial Distribution

  • M269341051 ()
  • 10381780000594 ()
  • 00381780000597 ()

  • 4 in x 10 in
34105

  • Collagen wound matrix dressing
Integra® Dermal Regeneration Template 4in. x 10in.
Integra Lifesciences Corporation
34041
In Commercial Distribution

  • M269341011 ()
  • 10381780000587 ()

  • 4 in x 10 in
34041

  • Collagen wound matrix dressing
INTEGRA Dermal Regeneration Template 4in. x 5in. (10cm x 12.5cm) is a bilayer membrane system for skin replacement. The dermal replacement layer is made of a porous matrix of fibers of cross-linked bovine tendon collagen and a glycosaminoglycan (chondroitin-6-sulfate) that is manufactured with a controlled porosity and defined degradation rate. The epidermal substitute layer is made of a thin polysiloxane (silicone) layer to control moisture loss from the wound.
Integra Lifesciences Corporation
34055
In Commercial Distribution

  • M269340551 ()
  • 10381780000570 ()
  • 00381780000573 ()

  • 4 in x 5 in
34055

  • Collagen wound matrix dressing
Integra® Dermal Regeneration Template 4in. x 5in. (10cm x 12.5cm)
Integra Lifesciences Corporation
34051
In Commercial Distribution

  • M269340511 ()
  • 10381780000563 ()

  • 4 in x 5 in
34051

  • Collagen wound matrix dressing
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