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.
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.
H2401JF
In Commercial Distribution

  • 00840682123761 ()


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

  • 00840682121644 ()


  • Stationary gamma camera system
No Description
Hangwei GE Medical Systems Co., Ltd.
5376496-15
In Commercial Distribution

  • 00840682117869 ()


  • Stationary gamma camera system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3100JY
In Commercial Distribution

  • 00840682115292 ()


  • Stationary gamma camera system
UFC GANTRY FINAL ASSEMBLY
G E MEDICAL SYSTEMS ISRAEL LTD.
H3000SA
In Commercial Distribution

  • 00840682105286 ()


  • Stationary gamma camera 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
NxSTEP Unweighing System, without Harness
BIODEX MEDICAL SYSTEMS, INC.
950-484
In Commercial Distribution

  • 00718175004845 ()
950-484

  • Mobile gait rehabilitation system, harness-support
Mobility Assist
BIODEX MEDICAL SYSTEMS, INC.
950-570
In Commercial Distribution

  • 00718175005705 ()
950-570

  • Gait rehabilitation electronic walker
NxSTEP Unweighing System, 115VAC
BIODEX MEDICAL SYSTEMS, INC.
950-485
In Commercial Distribution

  • 00718175004852 ()
950-485

  • Mobile gait rehabilitation system, harness-support
NxSTEP Unweighing System
BIODEX MEDICAL SYSTEMS, INC.
945-480
In Commercial Distribution

  • 00718175004807 ()
945-480

  • Mobile gait rehabilitation system, harness-support
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11668590
In Commercial Distribution

  • 04056869996295 ()


  • General-purpose ultrasound imaging system
Sentinella 102 is a mobile gamma camera system which is intended for imaging the distribution of radionuclides in the human body by means of photon detection. It provides scintigraphic images of specific parts of the body based on the detection of gamma rays emitted by the radioisotopes injected into patients. Sentinella presents the following modalities: • Sentinella 102 (this record) • Sentinella 102 Horus
GENERAL EQUIPMENT FOR MEDICAL IMAGING SA
SENTINELLA 102 HORUS
In Commercial Distribution

  • 08437018413027 ()

  • Height: 185 Centimeter
  • Depth: 77 Centimeter
  • Width: 63 Centimeter
  • Weight: 134 Kilogram
FP-0055

  • Mobile gamma camera system
Sentinella 102 is a mobile gamma camera system which is intended for imaging the distribution of radionuclides in the human body by means of photon detection. It provides scintigraphic images of specific parts of the body based on the detection of gamma rays emitted by the radioisotopes injected into patients. Sentinella presents the following modalities: • Sentinella 102 (this record) • Sentinella 102 Horus
GENERAL EQUIPMENT FOR MEDICAL IMAGING SA
SENTINELLA 102
In Commercial Distribution

  • 08437018413010 ()

  • Height: 185 Centimeter
  • Depth: 77 Centimeter
  • Width: 63 Centimeter
  • Weight: 134 Kilogram
FP-0040

  • Mobile gamma camera system
Gamma Camera System
Ddd-Diagnostic A/S
SoloMobile Gamma Camera System
In Commercial Distribution

  • 05711665004009 ()

  • Weight: 252 Kilogram
  • Height: 173 Centimeter
  • Depth: 138 Centimeter
  • Width: 70 Centimeter
9SOL2210

  • Mobile gamma camera system
Stat Profile pHOx Ultra/CCX Control CO-Ox Tri Level L7, 8 ,9 (amps)
NOVA BIOMEDICAL CORPORATION
phox ultra/ccx
In Commercial Distribution

  • 00385480491877 ()
  • 00385489491878 ()
49187

  • Assisted reproduction centrifuge tube
Stat Profile pHOx Ultra/CCX Control Chemistry L4, 5 (amps)
NOVA BIOMEDICAL CORPORATION
phox ultra/ccx
In Commercial Distribution

  • 00385480491846 ()
  • 00385489491847 ()
49184

  • Assisted reproduction centrifuge tube
Stat Profile pHOx Ultra/CCX Blood Gas Controls Multipack L1, 2, 3 (Amps)
NOVA BIOMEDICAL CORPORATION
phox ultra/ccx
In Commercial Distribution

  • 00385480489355 ()
  • 00385489489356 ()
48935

  • Assisted reproduction centrifuge tube
Xpert Flu kit; 10 test kit
CEPHEID
GXFLU-10A
Not in Commercial Distribution

  • 07332940001070 ()
GXFLU-10A

  • Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Smoke Shark III Smoke Evacuator 100V-120V 50/60Hz
Conmed Corporation
SE03-120
In Commercial Distribution

  • 20845854600099 ()
  • 10845854600092 ()
SE03-120

  • Surgical plume evacuation system
Smoke Shark III Smoke Evacuator 220V-240V 50/60Hz
Conmed Corporation
SE03-220
In Commercial Distribution

  • 20845854600082 ()
  • 10845854600085 ()
SE03-220

  • Surgical plume evacuation system
MiniVac Smoke Evacuation System 220-240V 50/60 Hz
Conmed Corporation
ECVV220
Not in Commercial Distribution

ECVV220

  • Surgical plume evacuation system
MiniVac Smoke Evacuation System 100V-120V 50/60 Hz
Conmed Corporation
ECVV120
In Commercial Distribution

  • 10614559104422 ()
  • 10845854053096 ()
  • 30845854053090 ()
ECVV120

  • Surgical plume evacuation system
TX NOZZLE STARTER KIT PACK, EVAC HOSE 9"" 5/PER BAG
ACUDERM, INC.
TXPACK-1
In Commercial Distribution

  • 00814105021668 ()


  • Surgical plume evacuation system
Rubber feet Acu-Evac 1E or Acu-Evac II when mounting on a tabletop or countertop
ACUDERM, INC.
CTFEET
In Commercial Distribution

  • 00814105020586 ()


  • Surgical plume evacuation system
Cart bracket for mounting of a Hyfrecator or other electrosurgical unit to an Evac cart, above the smoke evacuator
ACUDERM, INC.
CMB
In Commercial Distribution

  • 00814105020579 ()


  • Surgical plume evacuation system
Cart for mounting of Evac unit that provides portability and convenience. Unit has four wheels two of which swivel
ACUDERM, INC.
DUALCART
In Commercial Distribution

  • 00814105020562 ()


  • Surgical plume evacuation system
Wall mount bracket for mounting Acu-Evac IE-1 and Acu-Evac II to a wall
ACUDERM, INC.
EWMB
In Commercial Distribution

  • 00814105020555 ()


  • Surgical plume evacuation system
Pneumatic foot switch provides convenient ON-OFF control of Acu-Evac
ACUDERM, INC.
PFTSW
In Commercial Distribution

  • 00814105020548 ()


  • Surgical plume evacuation system
Flexible boom arm holds hose and nozzle in place for hands free operation. Not intended for use with lasers.
ACUDERM, INC.
ARM
In Commercial Distribution

  • 00814105020531 ()


  • Surgical plume evacuation system
Hose connector used to connect TX Pack or LTX Pack to hose
ACUDERM, INC.
HOSECON
In Commercial Distribution

  • 00814105020524 ()


  • Surgical plume evacuation system
6 ft. long x 1.3" diameter hose with connector for use with TX Pack or LTX Pack
ACUDERM, INC.
HOSE
In Commercial Distribution

  • 00814105020517 ()


  • Surgical plume evacuation system
Consists of a charcoal/odor filter and an ULPA filter-rated 99.9997% efficiency on particles 0..01 micron and 0.12 microns MPPS. Normal use filter life: 32 hours except for erbium smoke.
ACUDERM, INC.
M2-FILTER
In Commercial Distribution

  • 00814105020487 ()


  • Surgical plume evacuation system
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