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
DKVV120
Not in Commercial Distribution

  • 00815198011994 ()


  • Surgical plume evacuation system
Surgical Smoke Evacuator
Buffalo Filter
VV120NF
Not in Commercial Distribution

  • 00851136002853 ()


  • Surgical plume evacuation system
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