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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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one.click - 04054839025792

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 - 04054839025860

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 System - 00857167005030

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 System - 00857167005023

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

ePlex System - 00857167005016

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)

c.cam Imaging System - 04056869001272

No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
08419009
In Commercial Distribution

  • 04056869001272 ()
8419009..

  • Stationary gamma camera system

ZeroG-Passive System - 00850018836067

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

ZeroG-Lite Treadmill System - 00850018836234

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

ZeroG Gait & Balance System - 00850018836012

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 3-Dimensional BWS System - 00850018836265

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 - 10614559105344

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 - 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)

XL Pacer - 00858101008285

Gait Trainer
RIFTON EQUIPMENT
K650
In Commercial Distribution

  • 00858101008285 ()


  • Gait rehabilitation frame, manual

Walking Harness - Tollos - 00817956023126

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 - Tollos - 00817956023119

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 - Tollos - 00817956023102

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 - Tollos - 00817956023096

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 - Tollos - 00817956023089

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

WIPEABLE GAIT BELT 96" W/ PLASTIC BUCKLE YELLOW - 00733657216172

No Description
ALIMED, INC.
711779
In Commercial Distribution

  • 00733657216172 ()
2970008801

  • Movement-resistance gait rehabilitation device

WIPEABLE GAIT BELT 70IN W/ PLASTIC BUCKLE YELLOW - 00733657274523

No Description
ALIMED, INC.
713584
In Commercial Distribution

  • 00733657274523 ()
2970009328

  • Movement-resistance gait rehabilitation device

WIPEABLE GAIT BELT 70 INCH W/ PLASTIC BUCKLE ORANGE - 00733657216127

No Description
ALIMED, INC.
711023
In Commercial Distribution

  • 00733657216127 ()
2970008693

  • Movement-resistance gait rehabilitation device

WIPEABLE GAIT BELT 70 INCH W/ PLASTIC BUCKLE BLUE - 00733657216141

No Description
ALIMED, INC.
711029
In Commercial Distribution

  • 00733657216141 ()
2970008697

  • Movement-resistance gait rehabilitation device

WIPEABLE GAIT BELT 54IN W/ PLASTIC BUCKLE YELLOW - 00733657274516

No Description
ALIMED, INC.
713583
In Commercial Distribution

  • 00733657274516 ()
2970009326

  • Movement-resistance gait rehabilitation device

WIPEABLE GAIT BELT 54 INCH W/ PLASTIC BUCKLE BLUE - 00733657216134

No Description
ALIMED, INC.
711026
In Commercial Distribution

  • 00733657216134 ()
2970008694

  • Movement-resistance gait rehabilitation device

WIPEABLE GAIT BELT 54 INCH W/ PLASTIC BUCKLE ORANGE - 00733657216110

No Description
ALIMED, INC.
711020
In Commercial Distribution

  • 00733657216110 ()
2970008691

  • Movement-resistance gait rehabilitation device

WALLACH - 00888937013986

Biovac Smoke Evacuator (120 VAC)
Coopersurgical, Inc.
909070
In Commercial Distribution

  • 00888937013986 ()


  • Surgical plume evacuation system

VisiClear - 00815198012069

Surgical Smoke Evacuator with Filter
Buffalo Filter
VC120
Not in Commercial Distribution

  • 00815198012069 ()
  • 10815198012066 ()


  • Surgical plume evacuation system

VisiClear - 00815198012076

Surgical Smoke Evacuator
Buffalo Filter
VC120NF
Not in Commercial Distribution

  • 00815198012076 ()
  • 10815198012073 ()


  • Surgical plume evacuation system

ViroVac - 00815198011994

Surgical Smoke Evacuator
Buffalo Filter
DKVV120
Not in Commercial Distribution

  • 00815198011994 ()


  • Surgical plume evacuation system

ViroVac - 00851136002853

Surgical Smoke Evacuator
Buffalo Filter
VV120NF
Not in Commercial Distribution

  • 00851136002853 ()


  • Surgical plume evacuation system

ViroVac - 00851136002815

Surgical Smoke Evacuator with ViroVac Filter
Buffalo Filter
VV120
Not in Commercial Distribution

  • 00851136002815 ()


  • Surgical plume evacuation system

ViroVac - 00815198012168

Wall Mount Kit
Buffalo Filter
VVWM01
Not in Commercial Distribution

  • 00815198012168 ()


  • Surgical plume evacuation system

Ventri - 00840682121644

No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3000YT
In Commercial Distribution

  • 00840682121644 ()


  • Stationary gamma camera system

Vector Elite - 00815962020276

Vector Trolley Assembly, Elite Model
BIONESS INC.
VEC-1100
In Commercial Distribution

  • 00815962020276 ()


  • Gait rehabilitation frame, electric

Vector Elite - 00815962020269

Vector Gait and Safety System
BIONESS INC.
VEC-1000
In Commercial Distribution

  • 00815962020269 ()


  • Gait rehabilitation frame, electric

Vector Base - 00815962020283

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

  • 00815962020283 ()


  • Gait rehabilitation frame, manual

VISICLEAR - 20845854081355

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 - 20845854081348

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

  • 20845854081348 ()
VC220NF

  • Surgical plume evacuation system

VISICLEAR - 20845854081324

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

  • 20845854081324 ()
VC220

  • 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
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