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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one.click is a mechanical auto-injector which automatically administers a pre-set dose of Saizen (somatropin [rNDA origin]) in cartridges.
EMD Serono, Inc.
U1222402
Not in Commercial Distribution

  • 04054839025792 ()


  • Empty self-injector, mechanical
easypod is an electromechanical auto-injector which automatically administers a pre-set dose of Saizen (somatropin [rDNA origin]) in cartridges.
EMD Serono, Inc.
U1222102
Not in Commercial Distribution

  • 04054839025860 ()


  • Empty self-injector, electronic
ePlex Respiratory Panel Kit, 12 test, IVD
GENMARK DIAGNOSTICS, INC.
ePlex Respiratory Panel (RP)
In Commercial Distribution

  • 00857167005030 ()
EA001012

  • Multiple-genus respiratory virus antigen IVD, kit, multiplex
ePlex Sample Delivery Device RP Panel
GENMARK DIAGNOSTICS, INC.
ePlex Respiratory Panel (RP)
In Commercial Distribution

  • 00857167005023 ()
KT022006

  • Multiple-genus respiratory virus antigen IVD, kit, multiplex
Respiratory Panel Cartridge
GENMARK DIAGNOSTICS, INC.
ePlex Respiratory Panel (RP)
In Commercial Distribution

  • 00857167005016 ()
KT022287

  • Hepatitis G virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
08419009
In Commercial Distribution

  • 04056869001272 ()
8419009..

  • Stationary gamma camera system
The ZeroG-Passive System is intended to assist subjects with neurological and orthopedic injuries as they practice therapeutic activities related to walking, balance activities and postural control tasks. ZeroG-Passive should never be connected to inanimate objects. ZeroG-Passive should only be operated by therapists and trained healthcare professionals who have read and understand the instructions for use.
ARETECH, LLC
ZGP-110
In Commercial Distribution

  • 00850018836067 ()


  • Gait rehabilitation frame, manual
The ZeroG-Lite system is intended to assist patients with neurological and orthopedic injuries as they practice therapeutic activities related to walking, balance activities and postural control tasks. ZeroG-Lite should never be used to lift and transport patients, and should never be connected to inanimate objects. ZeroG-Lite should only be operated by therapists and trained healthcare professionals who have read and understand the instructions for use and have passed the ZeroG-Lite training competency exam conducted by an Aretech trainer or a certified staff trainer.
ARETECH, LLC
ZGL-V3
In Commercial Distribution

  • 00850018836234 ()


  • Gait rehabilitation frame, electric
The ZeroG Gait & Balance System is intended to assist subjects who have experienced neurological and orthopedic injuries as they practice therapeutic activities related to walking, balance activities and postural control tasks. ZeroG can also be used to train subjects ambulating on a treadmill. ZeroG should never be used to lift and transport subjects, and should never be connected to inanimate objects. ZeroG should only be operated by therapists and trained healthcare professionals who have read and understand the instructions for use and have passed the ZeroG training competency exam conducted by an Aretech trainer or a certified staff trainer.
ARETECH, LLC
ZGGB-V3
In Commercial Distribution

  • 00850018836012 ()


  • Gait rehabilitation frame, electric
ZeroG 3D is a robotic body-weight support system which automatically tracks patients as they move freely in any direction. The dynamic body-weight support offloads a percentage of the patient’s weight as they perform activities in a full 3-dimensional workspace, while the advanced fall protection provides the highest level of safety. The ZeroG 3D System is intended to assist subjects who have experienced neurological and orthopedic injures as they practice therapeutic activities related to walking and balance activities. ZeroG 3D can also be used to train subjects ambulating on a treadmill. ZeroG 3D should never be used to lift and transport subjects and should never be connected to inanimate objects. ZeroG 3D should only be operated by therapists and trained healthcare professionals who have read and understand the instructions for use and have passed the ZeroG 3D training competency exam conducted by an Aretech trainer or a certified staff trainer.
ARETECH, LLC
ZG3D-001
In Commercial Distribution

  • 00850018836265 ()


  • Gait rehabilitation frame, electric
ZIP Pen Ergonomic Smoke Evacuation Pencil E-Z Clean, Non-Stick, PTFE Coated, 10 Ft (3.04m) Tubing, 22mm Connector
MEGADYNE MEDICAL PRODUCTS, INC.
252510EC
In Commercial Distribution

  • 10614559105344 ()
  • 30614559105348 ()
252510EC

  • Surgical plume evacuation system
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)
Gait Trainer
RIFTON EQUIPMENT
K650
In Commercial Distribution

  • 00858101008285 ()


  • Gait rehabilitation frame, manual
Walking Harness - XXLarge - Orange Binding - 4 Loop - Tricot Material - Reuseable
1073849 Ontario Limited
TSC015WSXXX
In Commercial Distribution

  • 00817956023126 ()

  • Height: 21 Inch
  • Width: 16 Inch
  • Depth: 4 Inch


  • Gait rehabilitation system harness
Walking Harness - XLarge - Blue Binding - 4 Loop - Tricot Material - Reuseable
1073849 Ontario Limited
TSC015WSXX
In Commercial Distribution

  • 00817956023119 ()

  • Height: 21 Inch
  • Width: 16 Inch
  • Depth: 4 Inch


  • Gait rehabilitation system harness
Walking Harness - Large - Green Binding - 4 Loop - Tricot Material - Reuseable
1073849 Ontario Limited
TSC015WSX
In Commercial Distribution

  • 00817956023102 ()

  • Height: 21 Inch
  • Width: 16 Inch
  • Depth: 4 Inch


  • Gait rehabilitation system harness
Walking Harness - Medium - Yellow Binding - 4 Loop - Tricot Material - Reuseable
1073849 Ontario Limited
TSC015WS
In Commercial Distribution

  • 00817956023096 ()

  • Height: 21 Inch
  • Width: 17 Inch
  • Depth: 4 Inch


  • Gait rehabilitation system harness
Walking Harness - Small - Red Binding - 4 Loop - Tricot Material - Reuseable
1073849 Ontario Limited
TSC015WSP
In Commercial Distribution

  • 00817956023089 ()

  • Height: 21 Inch
  • Width: 17 Inch
  • Depth: 4 Inch


  • Gait rehabilitation system harness
No Description
ALIMED, INC.
711779
In Commercial Distribution

  • 00733657216172 ()
2970008801

  • Movement-resistance gait rehabilitation device
No Description
ALIMED, INC.
713584
In Commercial Distribution

  • 00733657274523 ()
2970009328

  • Movement-resistance gait rehabilitation device
No Description
ALIMED, INC.
711023
In Commercial Distribution

  • 00733657216127 ()
2970008693

  • Movement-resistance gait rehabilitation device
No Description
ALIMED, INC.
711029
In Commercial Distribution

  • 00733657216141 ()
2970008697

  • Movement-resistance gait rehabilitation device
No Description
ALIMED, INC.
713583
In Commercial Distribution

  • 00733657274516 ()
2970009326

  • Movement-resistance gait rehabilitation device
No Description
ALIMED, INC.
711026
In Commercial Distribution

  • 00733657216134 ()
2970008694

  • Movement-resistance gait rehabilitation device
No Description
ALIMED, INC.
711020
In Commercial Distribution

  • 00733657216110 ()
2970008691

  • Movement-resistance gait rehabilitation device
Biovac Smoke Evacuator (120 VAC)
Coopersurgical, Inc.
909070
In Commercial Distribution

  • 00888937013986 ()


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

  • 00815198012076 ()
  • 10815198012073 ()


  • 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
VV120NF
Not in Commercial Distribution

  • 00851136002853 ()


  • Surgical plume evacuation system
Surgical Smoke Evacuator with ViroVac Filter
Buffalo Filter
VV120
Not in Commercial Distribution

  • 00851136002815 ()


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

  • 00815198011994 ()


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

  • 00815198012168 ()


  • Surgical plume evacuation system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3000YT
In Commercial Distribution

  • 00840682121644 ()


  • Stationary gamma camera system
Vector Trolley Assembly, Elite Model
BIONESS INC.
VEC-1100
In Commercial Distribution

  • 00815962020276 ()


  • Gait rehabilitation frame, electric
Vector Gait and Safety System
BIONESS INC.
VEC-1000
In Commercial Distribution

  • 00815962020269 ()


  • Gait rehabilitation frame, electric
Vector Gait and Safety System, Base Model
BIONESS INC.
VEC-3000
In Commercial Distribution

  • 00815962020283 ()


  • Gait rehabilitation frame, manual
VisiClear Surgical Smoke Evacuator with Filter 100V-120V 50/60 Hz
Conmed Corporation
VC120
In Commercial Distribution

VC120

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

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

  • Surgical plume evacuation system
VisiClear Surgical Smoke Evacuator with Filter 220V-240V 50/60 Hz
Conmed Corporation
VC220P1
Not in Commercial Distribution

  • 20845854081355 ()
VC220P1

  • Surgical plume evacuation system
VisiClear Surgical Smoke Evacuator 220V-240V 50/60Hz
Conmed Corporation
VC220NF
Not in Commercial Distribution

  • 20845854081348 ()
VC220NF

  • Surgical plume evacuation system
VisiClear Surgical Smoke Evacuator with Filter 220V-240V 50/60 Hz
Conmed Corporation
VC220
In Commercial Distribution

  • 20845854081324 ()
VC220

  • Surgical plume evacuation system
ViroVac Smoke Evacuation System With ViroSafe 3-Port Filter 220V-240V 50/60 Hz
Conmed Corporation
ASVV220
In Commercial Distribution

  • 30845854648685 ()
ASVV220

  • Surgical plume evacuation system
ViroVac Surgical Smoke Evacuator With Filter 100V-120V 50/60 Hz
Conmed Corporation
VV120
In Commercial Distribution

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

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

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

  • Surgical plume evacuation system
ViroVac Wall Mount Kit
Conmed Corporation
VVWM01
In Commercial Distribution

VVWM01

  • Surgical plume evacuation system
ViroVac Surgical Smoke Evacuator With Filter 220V-240V 50/60 Hz
Conmed Corporation
DKVV220
In Commercial Distribution

  • 30845854081765 ()
DKVV220

  • Surgical plume evacuation system
ViroVac Surgical Smoke Evacuator With Filter 220V-240V 50/60 Hz
Conmed Corporation
VV220
In Commercial Distribution

  • 20845854081317 ()
VV220

  • Surgical plume evacuation system
Bariatric Harness for persons 300-600 lbs
M.A.S.S. Rehab, LLC
Bariatric
In Commercial Distribution

  • G505MRUHB0 ()


  • Gait rehabilitation system harness
Unloading harness for gait training
M.A.S.S. Rehab, LLC
Standard
In Commercial Distribution

  • G505MRUHS0 ()


  • Gait rehabilitation system harness
***NON-STERILE*** CLASSIC NASAL SLIMPACK W/STRING (500/SP)
Beaver-Visitec International, Inc.
NS10111-C
In Commercial Distribution

  • 30886158012284 ()
NS10111-C

  • ENT space-occupying dressing, human-derived
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