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
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-160
In Commercial Distribution

  • 09348215055899 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-159
In Commercial Distribution

  • 09348215055882 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-158
In Commercial Distribution

  • 09348215055875 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-182-024
In Commercial Distribution

  • 09348215055790 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-182-023
In Commercial Distribution

  • 09348215055783 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
101-139
In Commercial Distribution

  • 09348215055356 ()


  • Orthopaedic broach
GammaPro Straight Standard Probe for wireless ionizing radiation detection.
Kubtec
K0018C01
In Commercial Distribution

  • B619GPROSTDPROBE0 ()


  • Mobile gamma camera system
GammaPro Kit with Standard probe, Tablet and Carry Case used for wireless ionizing radiation detection.
Kubtec
K0018C02
In Commercial Distribution

  • B619GPROSTDKIT0 ()


  • Mobile gamma camera system
GammaPro Angled Standard Probe used for wireless ionizing radiation detection.
Kubtec
K0021C01
In Commercial Distribution

  • B619GPROSTDANGPROBE0 ()


  • Mobile gamma camera system
GammaPro Laparoscopic Probe used for wireless ionizing radiation detection.
Kubtec
K0020C01
In Commercial Distribution

  • B619GPROLAPPROBE0 ()


  • Mobile gamma camera system
GammaPro Laparoscopic Probe with Tablet and Carry Case used for wireless ionizing radiation detection.
Kubtec
K0020C02
In Commercial Distribution

  • B619GPROLAPKIT0 ()


  • Mobile gamma camera system
GammaPro High Sensitivity Probe used for wireless ionizing radiation detection.
Kubtec
K0019C01
In Commercial Distribution

  • B619GPROHISPROBE0 ()


  • Mobile gamma camera system
GammaPro Hi-Sense Probe with Tablet and Carry Case used for wireless ionizing radiation detection.
Kubtec
K0019C02
In Commercial Distribution

  • B619GPROHISKIT0 ()


  • Mobile gamma camera system
Table with installed software is used with wireless battery powered probes (different shapes and sizes) to detect a determined range of gamma radiation energies and maximizes sensitivity and directivity.
Kubtec
K0017C01
In Commercial Distribution

  • B619GPROCASETABL2 ()


  • 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 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 Evacuation Unit
Buffalo Filter
120V
Not in Commercial Distribution

  • 00815198012403 ()
60-8585-120

  • Surgical plume evacuation system
Wall Mount Kit
Buffalo Filter
VVWM01
Not in Commercial Distribution

  • 00815198012168 ()


  • Surgical plume evacuation system
Surgical Smoke Evacuator with Filter
Buffalo Filter
VC120
Not in Commercial Distribution

  • 00815198012069 ()
  • 10815198012066 ()


  • Surgical plume evacuation system
Surgical Smoke Evacuator
Buffalo Filter
220 V
Not in Commercial Distribution

  • 00815198012748 ()
FOVV220

  • Surgical plume evacuation system
Surgical Smoke Evacuator
Buffalo Filter
220V
Not in Commercial Distribution

  • 00815198012731 ()
HYVV220

  • Surgical plume evacuation system
Surgical Smoke Evacuator
Buffalo Filter
120V
Not in Commercial Distribution

  • 00815198012724 ()
HYVV120

  • Surgical plume evacuation system
Smoke Evacuation Unit
Buffalo Filter
220V
Not in Commercial Distribution

  • 00815198012410 ()
60-8585-230

  • Surgical plume evacuation system
Surgical Smoke Evacuator
Buffalo Filter
VC120NF
Not in Commercial Distribution

  • 00815198012076 ()
  • 10815198012073 ()


  • Surgical plume evacuation system
Surgical Smoke Evacuator
Buffalo Filter
DKVV120
Not in Commercial Distribution

  • 00815198011994 ()


  • Surgical plume evacuation system
Smoke Evacuation Tubing Support Stand
COASTAL LIFE TECHNOLOGIES, INC.
907001
In Commercial Distribution

  • 00814716020777 ()


  • Surgical plume evacuation system
Smoke Evacuator
COASTAL LIFE TECHNOLOGIES, INC.
906151
In Commercial Distribution

  • 00814716020357 ()


  • Surgical plume evacuation system
Smoke Evacuator
COASTAL LIFE TECHNOLOGIES, INC.
906150
In Commercial Distribution

  • 00814716020340 ()


  • Surgical plume evacuation system
Smoke Evacuator
COASTAL LIFE TECHNOLOGIES, INC.
906750
In Commercial Distribution

  • 00814716020074 ()


  • Surgical plume evacuation system
Smoke Evacuator
COASTAL LIFE TECHNOLOGIES, INC.
906760
In Commercial Distribution

  • 00814716020067 ()


  • Surgical plume evacuation system
Smoke Evacuator
COASTAL LIFE TECHNOLOGIES, INC.
906500
In Commercial Distribution

  • 00814716020050 ()


  • Surgical plume evacuation system
Includes TX Nozzle, preliminary filter, 18" hose section assembly, connects to Hose, Intended for long procedures of up to 1 hour duration
ACUDERM, INC.
LTXPACK
In Commercial Distribution

  • 10814105020507 ()


  • Surgical plume evacuation system
Includes TX Nozzle, preliminary filter, 8" hose section assembly, connects to Hose, Intended for short procedures of up to 15 minutes duration
ACUDERM, INC.
TXPACK
In Commercial Distribution

  • 10814105020491 ()


  • Surgical plume evacuation system
Top of the line surgical smoke evacuator. Specifically designed for use with erbium smoke. Also suitable for use with CO2, hair removal, and other laser or electrosurgical units in open procedures or with reducer for handpiece or 220vac motor
ACUDERM, INC.
EVAC II-2
In Commercial Distribution

  • 10814105020460 ()


  • Surgical plume evacuation system
Top of the line surgical smoke evacuator. Specifically designed for use with erbium smoke. Also suitable for use with CO2, hair removal, and other laser or electrosurgical units in open procedures or with reducer for handpiece or laparoscopic use. 110vac motor
ACUDERM, INC.
EVAC II-1
In Commercial Distribution

  • 10814105020453 ()


  • Surgical plume evacuation system
All purpose surgical smoke evacuator. Suitable for use with CO2, erbium, hair removal, and other laser or electrosurgical units in open procedures. 220vac motor
ACUDERM, INC.
EVAC IE-2
In Commercial Distribution

  • 10814105020446 ()


  • Surgical plume evacuation system
All purpose surgical smoke evacuator. Suitable for use with CO2, erbium, hair removal, and other laser or electrosurgical units in open procedures. 110vac motor
ACUDERM, INC.
EVAC IE-1
In Commercial Distribution

  • 10814105020439 ()


  • Surgical plume evacuation system
Wall Mount starter package includes Acu-Evac II, Wall mount bracket, M-1 main filter, Hose and 5 TX Nozzles
ACUDERM, INC.
STARTER-IIW
In Commercial Distribution

  • 10814105020422 ()


  • Surgical plume evacuation system
Wall Mount starter package includes Acu-Evac IE, Wall mount bracket, M-1 main filter, Hose and 5 TX Nozzles
ACUDERM, INC.
STARTER-IEW
In Commercial Distribution

  • 10814105020415 ()


  • Surgical plume evacuation system
Cart mount starter package includes Acu-Evac II unit, Cart, Boom Arm, Foot Switch, M-1 Main Filter, Hose and 5 TX Nozzles.
ACUDERM, INC.
STARTER-II
In Commercial Distribution

  • 10814105020408 ()


  • Surgical plume evacuation system
Cart mount starter package includes Acu-Evac IE unit, Cart, Boom Arm, Foot Switch, M-1 Main Filter, Hose and 5 TX Nozzles.
ACUDERM, INC.
STARTER-IE
In Commercial Distribution

  • 10814105020392 ()


  • Surgical plume evacuation system
No Description
NORTHGATE TECHNOLOGIES INC.
7-700-00
In Commercial Distribution

  • 00817183020684 ()


  • Surgical plume evacuation system
EQM-A : EvaQMax Auto Automatic Activation Device / 1 each/ reusable
MEDIMAX TECH INC.
EQM-A
In Commercial Distribution

  • 00817325023610 ()


  • Surgical plume evacuation system
EQM-FT : EvaQMax Fluid Trap - Fluid Trap for Unit / 20 pcs in one box / Each
MEDIMAX TECH INC.
EQM-FT
In Commercial Distribution

  • 00817325023603 ()


  • Surgical plume evacuation system
EQM-CAF : EvaQMax Filter for the EvaQMax Unit / each/ reusable
MEDIMAX TECH INC.
EQM-CAF
In Commercial Distribution

  • 10817325023570 ()
  • 00817325023573 ()


  • Surgical plume evacuation system
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