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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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ULPA Filter & Water Trap - 00817688021438

No Description
I.C. MEDICAL, INC.
ICM-000-0014
In Commercial Distribution

  • 00817688021445 ()
  • 00817688021438 ()


  • Surgical plume evacuation system

ULPA Box Filter - 00817688021674

No Description
I.C. MEDICAL, INC.
ICM-000-0289
In Commercial Distribution

  • 00817688021681 ()
  • 00817688021674 ()


  • Surgical plume evacuation system

ULPA Box Filter - 00817688021636

No Description
I.C. MEDICAL, INC.
ICM-000-0262
In Commercial Distribution

  • 00817688021643 ()
  • 00817688021636 ()


  • Surgical plume evacuation system

ULPA Box Filter - 00817688021773

No Description
I.C. MEDICAL, INC.
ICM-000-0460
In Commercial Distribution

  • 00817688021780 ()
  • 00817688021773 ()


  • Surgical plume evacuation system

ULPA Box Filter - 00817688021650

No Description
I.C. MEDICAL, INC.
ICM-000-0276
In Commercial Distribution

  • 00817688021667 ()
  • 00817688021650 ()


  • Surgical plume evacuation system

Trumpf - 30845854081000

Trumpf Medical Kit (1) VSTR08, (1) EZLINK01, (1) FS10004, (3) S-PA2010, (2) BLAP100V, (3) S-VTWT624
Conmed Corporation
TRUMPFKIT02
In Commercial Distribution

  • 30845854081000 ()
TRUMPFKIT02

  • Surgical plume evacuation system

Trexo Robotics - 00628719321072

Trexo Robotics XL Trexo Plus 1 Shipment
Trexo Robotics Inc.
A0001
In Commercial Distribution

  • 00628719321072 ()

  • XL
A001BPX

  • Programmable ambulation exoskeleton, clinical

Trexo Robotics - 00628719321065

Trexo Robotics Large Trexo Plus 1 Shipment
Trexo Robotics Inc.
A0001
In Commercial Distribution

  • 00628719321065 ()

  • Large
A001BPR

  • Programmable ambulation exoskeleton, clinical

Trexo Robotics - 00628719321058

Trexo Robotics Medium Trexo Plus 1 Shipment
Trexo Robotics Inc.
A0001
In Commercial Distribution

  • 00628719321058 ()

  • Medium
A001BPR

  • Programmable ambulation exoskeleton, clinical

Trexo Robotics - 00628719321041

Trexo Robotics Small Trexo Plus 1 Shipment
Trexo Robotics Inc.
A0001
In Commercial Distribution

  • 00628719321041 ()

  • Small
A001BPR

  • Programmable ambulation exoskeleton, clinical

THIN GAIT BELT 54 INCH 20/CA - 00733657286090

No Description
ALIMED, INC.
71243720
In Commercial Distribution

  • 00733657286090 ()
  • 00733657300321 ()
2970008985

  • Movement-resistance gait rehabilitation device

THIN GAIT BELT 54 INCH - 00733657232141

No Description
ALIMED, INC.
712437
In Commercial Distribution

  • 00733657232141 ()
2970008984

  • Movement-resistance gait rehabilitation device

THERA-Trainer lyra - 04041925002775

The gait trainer conveys mechanical energy needed to perform gait therapy via foot plates to the sole of the patient’s feet. The foot plates follow a pattern that is derived from healthy subjects. The body weight support system secures the patient from falling and further allows to reduce the weight on the patient’s feet.
medica - Medizintechnik GmbH
01.XX.XX
In Commercial Distribution

  • 04041925002775 ()


  • Treadmill/elliptical gait rehabilitation system

System Kit, ALS HDE - 00852184003281

No Description
Synapse Biomedical, Inc.
20-0045
In Commercial Distribution

  • 00852184003281 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

System Destination Kit, SCI HDE, US - 00852184003298

No Description
Synapse Biomedical, Inc.
20-0061
In Commercial Distribution

  • 00852184003298 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

System Destination Kit, CE 2 EPG - 00852184003069

No Description
Synapse Biomedical, Inc.
20-0063
In Commercial Distribution

  • 00852184003069 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

System Destination Kit, ALS HDE, US - 00852184003304

No Description
Synapse Biomedical, Inc.
20-0062
In Commercial Distribution

  • 00852184003304 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

System Destination Kit, ALS CE - 00852184003076

No Description
Synapse Biomedical, Inc.
20-0064
In Commercial Distribution

  • 00852184003076 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

System Destination Kit, 2-EPG, Canada - 00852184003311

No Description
Synapse Biomedical, Inc.
20-0065
In Commercial Distribution

  • 00852184003311 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

Symbia_Evo_Excel - 04056869001265

No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10910501
In Commercial Distribution

  • 04056869001265 ()


  • Stationary gamma camera system

Symbia_Evo - 04056869001258

No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10910500
In Commercial Distribution

  • 04056869001258 ()


  • Stationary gamma camera system

Symbia S Series - 04056869001166

No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
08717741
In Commercial Distribution

  • 04056869001166 ()


  • Stationary gamma camera system

Symbia E Single Head System - 04056869002729

No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10413009
In Commercial Distribution

  • 04056869002729 ()


  • Stationary gamma camera system

Symbia E Dual Head System - 04056869001159

No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10275879
In Commercial Distribution

  • 04056869001159 ()


  • Stationary gamma camera system

Surgimedics® - 00814716020777

Smoke Evacuation Tubing Support Stand
COASTAL LIFE TECHNOLOGIES, INC.
907001
In Commercial Distribution

  • 00814716020777 ()


  • Surgical plume evacuation system

Surgimedics® - 00814716020357

Smoke Evacuator
COASTAL LIFE TECHNOLOGIES, INC.
906151
In Commercial Distribution

  • 00814716020357 ()


  • Surgical plume evacuation system

Surgimedics® - 00814716020340

Smoke Evacuator
COASTAL LIFE TECHNOLOGIES, INC.
906150
In Commercial Distribution

  • 00814716020340 ()


  • Surgical plume evacuation system

Surgimedics® - 00814716020074

Smoke Evacuator
COASTAL LIFE TECHNOLOGIES, INC.
906750
In Commercial Distribution

  • 00814716020074 ()


  • Surgical plume evacuation system

Surgimedics® - 00814716020067

Smoke Evacuator
COASTAL LIFE TECHNOLOGIES, INC.
906760
In Commercial Distribution

  • 00814716020067 ()


  • Surgical plume evacuation system

Surgimedics® - 00814716020050

Smoke Evacuator
COASTAL LIFE TECHNOLOGIES, INC.
906500
In Commercial Distribution

  • 00814716020050 ()


  • Surgical plume evacuation system

Surgical Site Start-up Kit, ALS HDE - 00852184003328

No Description
Synapse Biomedical, Inc.
20-0070
In Commercial Distribution

  • 00852184003328 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

Surgical Connector Kit - 00852184003410

No Description
Synapse Biomedical, Inc.
22-0028
In Commercial Distribution

  • 00852184003410 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

StrykeVac 3 - 00851136002549

Surgical Smoke Evacuation System
Buffalo Filter
SV3120V
Not in Commercial Distribution

  • 00851136002549 ()
SV3120V

  • Surgical plume evacuation system

Stat Profile - 00385480524278

Prime Calibrator Cartridge CCS Comp 300 Sample
NOVA BIOMEDICAL CORPORATION
PRIME
In Commercial Distribution

  • 00385480524278 ()
52427

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
  • Assisted reproduction centrifuge tube

StarGuide - 00195278118295

STARGATE NM GANTRY FINAL
G E MEDICAL SYSTEMS ISRAEL LTD.
H3911AB
In Commercial Distribution

  • 00195278118295 ()


  • Stationary gamma camera system
  • Full-body CT system

Spare Surgical Kit - 00852184003267

No Description
Synapse Biomedical, Inc.
20-0040
In Commercial Distribution

  • 00852184003267 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation 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

Socket Pusher - 00852184003496

No Description
Synapse Biomedical, Inc.
23-0010
In Commercial Distribution

  • 00852184003496 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

Smoke Shark III - 10845854600092

Smoke Shark III Smoke Evacuator 100V-120V 50/60Hz
Conmed Corporation
SE03-120
In Commercial Distribution

  • 20845854600099 ()
  • 10845854600092 ()
SE03-120

  • Surgical plume evacuation system

Smoke Shark III - 10845854600085

Smoke Shark III Smoke Evacuator 220V-240V 50/60Hz
Conmed Corporation
SE03-220
In Commercial Distribution

  • 20845854600082 ()
  • 10845854600085 ()
SE03-220

  • Surgical plume evacuation system

Small Pacer - 00850001752244

Gait Trainer
RIFTON EQUIPMENT
K620
In Commercial Distribution

  • 00850001752244 ()


  • Gait rehabilitation frame, manual

Skytron Smoke Evacuation - 10841736114992

Smoke evacuation system 220V for Ergon 2 and 3, includes pneumatic foot switch. Requires H8-300-41-A mounting bracket. AIR SAFE filters required and QUIKLINK automatic activation device sold separately.
SKYTRON LLC
ELVV220
In Commercial Distribution

  • 10841736114992 ()


  • Surgical plume evacuation system

Skytron - 10841736100810

Smoke Evacuation System for Models Ergon 2 and 3, includes pneumatic foot switch. Requires H8-300-41-A mounting bracket. AIR SAFE filters and QUIKLINK automatic activation device sold separately.
SKYTRON LLC
SMOKE-E-VAC
In Commercial Distribution

  • 10841736100810 ()
SMOKE-E-VAC

  • Surgical plume evacuation system

Skytron - 10841736100773

Automatic activation device for Smoke-e-vac
SKYTRON LLC
QUIKLINK
In Commercial Distribution

  • 10841736100773 ()
QUIKLINK

  • Surgical plume evacuation system

Simplexa™ Influenza A H1N1 (2009) - 20816101025521

No Description
DIASORIN MOLECULAR LLC
MOL2500
In Commercial Distribution

  • 20816101025521 ()


  • Influenza A virus H1N1 subtype (swine influenza) nucleic acid IVD, kit, nucleic acid technique (NAT)

Silicone Adhesive Kit - 00852184003359

No Description
Synapse Biomedical, Inc.
22-0009
In Commercial Distribution

  • 00852184003359 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

SaftEvac - 00609960001302

EVACUATOR, SAFTEVAC, 110 VOLT
DERMATOLOGIC LAB AND SUPPLY, INC.
EV-I
In Commercial Distribution

  • 00609960001302 ()
EV-I

  • Surgical plume evacuation system

STERIS - 00817688023524

ICM-000-0645 STERIS Foot Switch
I.C. MEDICAL, INC.
SSESEN03
In Commercial Distribution

  • 00817688023524 ()
SSESEN03

  • Surgical plume evacuation system

STERIS - 00817688023517

ICM-000-0644 STERIS Laser Sensor
I.C. MEDICAL, INC.
SSESEN02
In Commercial Distribution

  • 00817688023517 ()
SSESEN02

  • Surgical plume evacuation system

STERIS - 00817688023500

ICM-000-0643 STERIS RF Sensor, Shielded
I.C. MEDICAL, INC.
SSESEN01
In Commercial Distribution

  • 00817688023500 ()
SSESEN01

  • Surgical plume evacuation system
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