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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No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
670 DR
In Commercial Distribution

  • 00840682139359 ()


  • Stationary gamma camera system
  • Full-body CT system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
NMCT640
In Commercial Distribution

  • 00840682139281 ()


  • Full-body CT system
  • Stationary gamma camera system
D630 NM GANTRY FINAL - NEW ROTOR
G E MEDICAL SYSTEMS ISRAEL LTD.
NM 630
In Commercial Distribution

  • 00840682139274 ()


  • Stationary gamma camera system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
Gantry UPG
In Commercial Distribution

  • 00840682138758 ()


  • Stationary gamma camera system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
Biopsy
In Commercial Distribution

  • 00840682138741 ()


  • Stationary gamma camera system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
Gantry
In Commercial Distribution

  • 00840682138697 ()


  • Stationary gamma camera system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
670 DR
In Commercial Distribution

  • 00840682124393 ()


  • Stationary gamma camera system
  • Full-body CT system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
NMCT 670 ES
In Commercial Distribution

  • 00840682123877 ()


  • Full-body CT system
  • Stationary gamma camera system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
NMCT 670 CZT
In Commercial Distribution

  • 00840682123853 ()


  • Full-body CT system
  • Stationary gamma camera system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3906AL
In Commercial Distribution

  • 00840682123778 ()


  • Full-body CT system
  • Stationary gamma camera system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H2401JF
In Commercial Distribution

  • 00840682123761 ()


  • Stationary gamma camera system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3100ZP
In Commercial Distribution

  • 00840682123754 ()


  • Stationary gamma camera system
  • Full-body CT system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3100CF
In Commercial Distribution

  • 00840682123747 ()


  • Stationary gamma camera system
  • Full-body CT system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3100ZC
In Commercial Distribution

  • 00840682123730 ()


  • Full-body CT system
  • Stationary gamma camera system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3000YT
In Commercial Distribution

  • 00840682121644 ()


  • Stationary gamma camera system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3906AB
In Commercial Distribution

  • 00840682121446 ()


  • Stationary gamma camera system
  • Full-body CT system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3100AH
In Commercial Distribution

  • 00840682121194 ()


  • Full-body CT system
  • Stationary gamma camera system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3100AG
In Commercial Distribution

  • 00840682121187 ()


  • Stationary gamma camera system
  • Full-body CT system
D630 to D670 DR NM GANTRY UPGRADE KIT
G E MEDICAL SYSTEMS ISRAEL LTD.
H3101RS
In Commercial Distribution

  • 00195278794772 ()
5953035

  • Stationary gamma camera system
  • Full-body CT system
870 DR NM GANTRY FINAL WITH NEW ROTOR - MDR CE
G E MEDICAL SYSTEMS ISRAEL LTD.
870 DR
In Commercial Distribution

  • 00195278788269 ()


  • Stationary gamma camera system
  • Full-body CT system
830 NM GANTRY FINAL WITH NEW ROTOR - MDR CE
G E MEDICAL SYSTEMS ISRAEL LTD.
830
In Commercial Distribution

  • 00195278788252 ()
5376204-33

  • Stationary gamma camera system
MyoSPECT ES to MyoSPECT Upgrade kit
G E MEDICAL SYSTEMS ISRAEL LTD.
H3912BS
In Commercial Distribution

  • 00195278722546 ()
5941445

  • Stationary gamma camera system
MyoSPECT ES MDR GANTRY
G E MEDICAL SYSTEMS ISRAEL LTD.
H3912BD
In Commercial Distribution

  • 00195278488626 ()
5875815-40

  • Stationary gamma camera system
MyoSPECT MDR GANTRY
G E MEDICAL SYSTEMS ISRAEL LTD.
H3912BC
In Commercial Distribution

  • 00195278488619 ()
5875815-30

  • Stationary gamma camera system
MyoSPECT GANTRY
G E MEDICAL SYSTEMS ISRAEL LTD.
H3912AA
In Commercial Distribution

  • 00195278421586 ()
5875815-10

  • Stationary gamma camera system
MyoSPECT ES GANTRY
G E MEDICAL SYSTEMS ISRAEL LTD.
H3912AB
In Commercial Distribution

  • 00195278421579 ()
5875815-20

  • Stationary gamma camera system
STARGATE NM GANTRY FINAL
G E MEDICAL SYSTEMS ISRAEL LTD.
H3911AB
In Commercial Distribution

  • 00195278118295 ()


  • Stationary gamma camera system
  • Full-body CT system
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
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