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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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SafeGait Active 360 Dynamic Mobility Trainer - 00860012112838

SafeGait Active 360 system (Model SGA360) is designed to assist a patient with walking/balance impediments to exercise and/or regain normal gait. SafeGait Active 360 system tethers patients with a dedicated harness hanging from a powered pneumatic braking device on the overhead aluminum rails moved by pulling force from the patient. SafeGait Active 360 system reduces clinician’s workload when helping patients to exercise or relearn the gait in a safe 3D environment. SafeGait Active 360 system shall only be operated by trained clinicians, therapists or DIH staff.
DIH TECHNOLOGY INC.
SGA360
In Commercial Distribution

  • 00860012112838 ()


  • Gait rehabilitation frame, electric

SafeGait Active Dynamic Mobility Trainer - 00860012112821

SafeGait Active S1000 system (Model SGAS1000) is designed to assist a patient with some impediments in walking/balance to exercise and/or to regain normal gait. SafeGait Active S1000 system tethers patients with a dedicated harness hanging from a powered pneumatic braking device on the overhead steel rails moved by pulling force from the patient. SafeGait Active S1000 system reduces clinician’s workload when helping patients to exercise or relearn the gait in a safe 3D environment. SafeGait Active S1000 system shall only be operated by trained clinicians, therapists or DIH staff.
DIH TECHNOLOGY INC.
SGAS1000
In Commercial Distribution

  • 00860012112821 ()


  • Gait rehabilitation frame, electric

SafeGait 360 Balance and Mobility Trainer - 00860012112814

SafeGait 360 system (Model SG360) is a body weight support system designed to assist a patient with a walking/balance disability to regain mobility via exercise and gait training. SafeGait 360 system tethers patients with a dedicated harness hanging from a powered device running on the overhead aluminum rails to offload the patient’s weight to various levels configurable via a computer or a handheld device. SafeGait 360 system reduces clinician’s workload when helping patients to exercise or relearn the gait in a safe 3D environment. SafeGait 360 system shall only be operated by trained clinicians, therapists or DIH staff.
DIH TECHNOLOGY INC.
SG360
In Commercial Distribution

  • 00860012112814 ()


  • Gait rehabilitation frame, electric

ACUSON Origin Diagnostic Ultrasound System - 04056869996295

No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11668590
In Commercial Distribution

  • 04056869996295 ()


  • General-purpose ultrasound imaging system

Origin Short 125deg Trial Neck - 09348215081423

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-182-027
In Commercial Distribution

  • 09348215081423 ()


  • Surgical implant template, reusable

Origin Stem Size 18 Template - 09348215055967

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-168
In Commercial Distribution

  • 09348215055967 ()


  • Surgical implant template, reusable

Origin Stem Size 15 Template - 09348215055943

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-165
In Commercial Distribution

  • 09348215055943 ()


  • Surgical implant template, reusable

Origin Stem Size 8 Template - 09348215055875

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-158
In Commercial Distribution

  • 09348215055875 ()


  • Surgical implant template, reusable

Origin DAA Trial Neck HO - 09348215055790

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-182-024
In Commercial Distribution

  • 09348215055790 ()


  • Surgical implant template, reusable

Origin Starter Broach (Chilly Pepper) - 09348215055356

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
101-139
In Commercial Distribution

  • 09348215055356 ()


  • Orthopaedic broach

Origin Stem Size 20 Template - 09348215055974

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-170
In Commercial Distribution

  • 09348215055974 ()


  • Surgical implant template, reusable

Origin Stem Size 16 Template - 09348215055950

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-166
In Commercial Distribution

  • 09348215055950 ()


  • Surgical implant template, reusable

Origin Stem Size 14 Template - 09348215055936

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-164
In Commercial Distribution

  • 09348215055936 ()


  • Surgical implant template, reusable

Origin Stem Size 13 Template - 09348215055929

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-163
In Commercial Distribution

  • 09348215055929 ()


  • Surgical implant template, reusable

Origin Stem Size 12 Template - 09348215055912

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-162
In Commercial Distribution

  • 09348215055912 ()


  • Surgical implant template, reusable

Origin Stem Size 11 Template - 09348215055905

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-161
In Commercial Distribution

  • 09348215055905 ()


  • Surgical implant template, reusable

Origin Stem Size 10 Template - 09348215055899

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-160
In Commercial Distribution

  • 09348215055899 ()


  • Surgical implant template, reusable

Origin Stem Size 9 Template - 09348215055882

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-159
In Commercial Distribution

  • 09348215055882 ()


  • Surgical implant template, reusable

Origin DAA Trial Neck SO - 09348215055783

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-182-023
In Commercial Distribution

  • 09348215055783 ()


  • Surgical implant template, reusable

SENTINELLA - 08437018413027

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 - 08437018413010

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

SoloMobile - 05711665004009

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 - 00385480491877

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 - 00385480491846

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 - 00385480489355

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 - 07332940001070

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)

NA - 30845854082014

Isolation Transformer
Conmed Corporation
333596
In Commercial Distribution

  • 30845854082014 ()
333596

  • Surgical plume evacuation system

VIROVAC - 30845854081956

ViroVac Surgical Smoke Evacuator with Filter 100V-120V 50/60Hz
Conmed Corporation
VV120
In Commercial Distribution

  • 10845854081969 ()
  • 30845854081956 ()
  • 00851136002815 ()
VV120

  • Surgical plume evacuation system

VIROVAC - 30845854081888

ViroVac Wall Mount Kit
Conmed Corporation
VVWM01
In Commercial Distribution

VVWM01

  • Surgical plume evacuation system

NA - 30845854081734

CIMPAX VIROVAC 220V
Conmed Corporation
C32-01-750
In Commercial Distribution

  • 30845854081734 ()
C32-01-750

  • Surgical plume evacuation system

NA - 30845854081673

smokeStar 220/240V
Conmed Corporation
MH100016
In Commercial Distribution

  • 30845854081673 ()
MH100016

  • Surgical plume evacuation system

PLUMEVAC - 30845854081659

PlumeVac Surgical Smoke Evacuator 100V-120V 50/60 Hz
Conmed Corporation
AEVV220
In Commercial Distribution

  • 30845854081659 ()
AEVV220

  • Surgical plume evacuation system

CLEARVIEW - 30845854081208

ClearView Smoke Evacuation Unit with ClearView Smoke Evacuator Filter 100V-120V 50/60Hz
Conmed Corporation
60-8585-120
In Commercial Distribution

60-8585-120

  • Surgical plume evacuation system

CLEARVIEW - 30845854081178

ClearView Smoke Evacuation Unit with ClearView Smoke Evacuator Filter 220V-240V 50/60Hz
Conmed Corporation
60-8585-230
In Commercial Distribution

60-8585-230

  • Surgical plume evacuation system

LUMENIS - 30845854081130

PSWTURBO 120V SMOKE EVACUATOR/FILTER/NON-STERILE TUBING
Conmed Corporation
LU3303-0255
In Commercial Distribution

  • 30845854081130 ()
LU3303-0255

  • Surgical plume evacuation system

OR-VAC - 30845854081031

OR-VAC Surgical Smoke Plume Evacuator with Filter 100V-120V 50/60 Hz
Conmed Corporation
HYVV120
In Commercial Distribution

  • 10845854081037 ()
  • 30845854081031 ()
  • 00815198012724 ()
HYVV120

  • Surgical plume evacuation system

FUMOVAC - 30845854061408

FUMOVAC 700 Complete Unit 220/240 V 50/60 Hz
Conmed Corporation
57525420
In Commercial Distribution

  • 30845854061408 ()
  • 10845854061404 ()
57525420

  • Surgical plume evacuation system

SMOKE-E-VAC - 30845854061163

Surgical Smoke Plume Evacuator 100V-120V 50/60Hz
Conmed Corporation
PLVV120
In Commercial Distribution

  • 30845854061163 ()
PLVV120

  • Surgical plume evacuation system

NA - 30845854061071

Surgical Smoke Evacuation System 100V-120V 50/60 Hz
Conmed Corporation
SV3120V
In Commercial Distribution

  • 10845854061077 ()
  • 30845854061071 ()
  • 00851136002549 ()
SV3120V

  • Surgical plume evacuation system

PLUMEVAC - 30845854061040

PlumeVac Surgical Smoke Evacuator 100V-120V 50/60 Hz
Conmed Corporation
AEVV120
In Commercial Distribution

  • 30845854061040 ()
AEVV120

  • Surgical plume evacuation system

VIROVAC - 30845854648685

VIROVAC SMOKE EVACUATION SYSTEM WITH VIROSAFE 3-PORT FILTER 220V-240V 50/60HZ
Conmed Corporation
ASVV220
In Commercial Distribution

  • 30845854648685 ()
ASVV220

  • Surgical plume evacuation system

VISICLEAR - 30845854081970

VisiClear Surgical Smoke Evacuator with Filter 100V-120V 50/60 Hz
Conmed Corporation
VC120
In Commercial Distribution

VC120

  • Surgical plume evacuation system

VISICLEAR - 30845854081963

VisiClear Surgical Smoke Evacuator 100V-120V 50/60 Hz
Conmed Corporation
VC120NF
In Commercial Distribution

  • 10845854081976 ()
  • 30845854081963 ()
  • 00815198012076 ()
VC120NF

  • Surgical plume evacuation system

VIROVAC - 30845854081949

ViroVac Surgical Smoke Evacuator 100V-120V 50/60Hz
Conmed Corporation
VV120NF
In Commercial Distribution

  • 10845854081952 ()
  • 30845854081949 ()
  • 00851136002853 ()
VV120NF

  • Surgical plume evacuation system

PLUMESAFE - 30845854081901

PlumeSafe TURBO Surgical Smoke Evacuator 100V-120V 50/60 Hz
Conmed Corporation
PSWTURBO_AS
In Commercial Distribution

PSWTURBO_AS

  • Surgical plume evacuation system

VIROVAC - 30845854081765

ViroVac Surgical Smoke Evacuator with Filter 220V-240V 50/60Hz
Conmed Corporation
DKVV220
In Commercial Distribution

  • 30845854081765 ()
DKVV220

  • Surgical plume evacuation system

LUMENIS - 30845854081291

PSWTURBO 220V SMOKE EVACUATOR/FILTER/NON-STERILE TUBING
Conmed Corporation
LU3303-0257
In Commercial Distribution

  • 30845854081291 ()
LU3303-0257

  • Surgical plume evacuation system

CYNOSURE - 30845854081116

CYNOSURE VIROVAC 220V SMOKE EVACUATOR/FILTER/NON-STERILE TUBING
Conmed Corporation
CYNOSUREVV220K
In Commercial Distribution

  • 30845854081116 ()
CYNOSUREVV220K

  • Surgical plume evacuation system

OR-VAC - 30845854081048

OR-VAC Surgical Smoke Plume Evacuator with Filter 220V-240V 50/60 Hz
Conmed Corporation
HYVV220
In Commercial Distribution

  • 10845854081044 ()
  • 30845854081048 ()
  • 00815198012731 ()
HYVV220

  • Surgical plume evacuation system

OR-VAC - 30845854081024

OR-VAC Surgical Smoke Plume Evacuator with Filter 220V-240V 50/60 Hz
Conmed Corporation
FOVV220
In Commercial Distribution

  • 10845854081020 ()
  • 30845854081024 ()
  • 00815198012748 ()
FOVV220

  • Surgical plume evacuation system
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