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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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StrykeVac 3 - 00851136002549

Surgical Smoke Evacuation System
Buffalo Filter
SV3120V
Not in Commercial Distribution

  • 00851136002549 ()
SV3120V

  • Surgical plume evacuation system

PlumeSafe - 00851136002419

Surgical Smoke Evacuator with Filter
Buffalo Filter
PSWTURBO AS
Not in Commercial Distribution

  • 00851136002419 ()


  • Surgical plume evacuation system

EvacuCart - 00851136002396

Portable Cart for Smoke Evacuators
Buffalo Filter
ETC01
Not in Commercial Distribution

  • 00851136002396 ()


  • Surgical plume evacuation system

Porta PlumeSafe - 00851136002044

Surgical Smoke Evacuator
Buffalo Filter
PPS604
Not in Commercial Distribution

  • 00851136002044 ()


  • Surgical plume evacuation system

Aegis Air Filtration System Unit Suction Cover - 00872320005719

Unit suction cover for the Aegis Air Filtration Unit - A Portable air filtration station to remove particulates and contaminants from the air within an enclosed room or space.
CAO GROUP, INC.
005-00089
In Commercial Distribution

  • 00872320005719 ()


  • Surgical plume evacuation system

Aegis Air Filtration System Unit Filtration Cover - 00872320005702

Unit filtration cover for the Aegis Air Filtration Unit - A Portable air filtration station to remove particulates and contaminants from the air within an enclosed room or space.
CAO GROUP, INC.
005-00088
In Commercial Distribution

  • 00872320005702 ()


  • Surgical plume evacuation system

Aegis Air Filtration System - 00872320005696

Portable air filtration station to remove particulates and contaminants from the air within an enclosed room or space.
CAO GROUP, INC.
005-00087
In Commercial Distribution

  • 00872320005696 ()


  • Surgical plume evacuation system

Aegis Aerosol VacStation Small Inlet Collector - 00872320005603

Replacement small square inlet collector for the Aegis Aerosol VacStation.
CAO GROUP, INC.
005-00086
In Commercial Distribution

  • 00872320005603 ()


  • Surgical plume evacuation system

Aegis Aerosol VacStation Primary Filter - 00872320005504

Replacement primary cotton filter for the Aegis Aerosol VacStation.
CAO GROUP, INC.
005-00046
In Commercial Distribution

  • 00872320005450 ()
  • 00872320005504 ()


  • Surgical plume evacuation system

Aegis Aerosol VacStation Primary Filter - 00872320005498

Replacement inlet collector for the Aegis Aerosol VacStation.
CAO GROUP, INC.
005-00050
In Commercial Distribution

  • 00872320005498 ()


  • Surgical plume evacuation system

Aegis Aerosol VacStation Primary Filter - 00872320005481

Replacement collection tube for the Aegis Aerosol VacStation.
CAO GROUP, INC.
005-00049
In Commercial Distribution

  • 00872320005481 ()


  • Surgical plume evacuation system

Aegis Aerosol VacStation Primary Filter - 00872320005474

Replacement charcoal filter cartridge for the Aegis Aerosol VacStation.
CAO GROUP, INC.
005-00048
In Commercial Distribution

  • 00872320005474 ()


  • Surgical plume evacuation system

Aegis Aerosol VacStation Primary Filter - 00872320005467

Replacement secondary fiberglass filter for the Aegis Aerosol VacStation.
CAO GROUP, INC.
005-00047
In Commercial Distribution

  • 00872320005467 ()


  • Surgical plume evacuation system

Aegis Aerosol VacStation - 00872320004958

Plume vacuum station to provide suction for removing plume, spray, and particulates generated during dental procedures.
CAO GROUP, INC.
005-00045
In Commercial Distribution

  • 00872320004958 ()


  • 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)

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

CorMatrix(R) Cor(TM) PATCH Epicardial Patch, Five Pack, 7cm x 10cm - 00850003965017

CorMatrix Cor PATCH is intended for epicardial tissue support and repair.
CORMATRIX CARDIOVASCULAR, INC.
CMCP5P-710
In Commercial Distribution

  • 00850003965017 ()

  • Width: 10 Centimeter
  • Length: 7 Centimeter


  • Cardiovascular patch, animal-derived

CorMatrix(R) Cor(TM) PATCH Epicardial Patch, Five Pack, 5cm x 5cm - 00850003965000

CorMatrix Cor PATCH is intended for epicardial tissue support and repair.
CORMATRIX CARDIOVASCULAR, INC.
CMCP5P-055
In Commercial Distribution

  • 00850003965000 ()

  • Length: 5 Centimeter


  • Cardiovascular patch, animal-derived

Morning Walk - 08800043810121

No Description
CUREXO, Inc.
MW-V100
In Commercial Distribution

  • 08800043810121 ()


  • Treadmill/elliptical gait rehabilitation system

Morning Walk - 08800043810022

MW-S200
CUREXO, Inc.
MW-S200
In Commercial Distribution

  • 08800043810022 ()
AC-00000-000

  • Treadmill/elliptical gait rehabilitation system

HAL for Medical Use - 04560340091091

Number of legs: Double Leg length: eXtra long Hip width: Wide
CYBERDYNE, INC.
HAL-ML05-DXWUS
In Commercial Distribution

  • 04560340091091 ()


  • Neuro-controlled ambulation exoskeleton

HAL for Medical Use - 04560340091084

Number of legs: Double Leg length: Long Hip width: Wide
CYBERDYNE, INC.
HAL-ML05-DLWUS
In Commercial Distribution

  • 04560340091084 ()


  • Neuro-controlled ambulation exoskeleton

HAL for Medical Use - 04560340091077

Number of legs: Double Leg length: Medium Hip width: Wide
CYBERDYNE, INC.
HAL-ML05-DMWUS
In Commercial Distribution

  • 04560340091077 ()


  • Neuro-controlled ambulation exoskeleton

HAL for Medical Use - 04560340091060

Number of legs: Double Leg length: Short Hip width: Wide
CYBERDYNE, INC.
HAL-ML05-DSWUS
In Commercial Distribution

  • 04560340091060 ()


  • Neuro-controlled ambulation exoskeleton

HAL for Medical Use - 04560340090971

Number of legs: Double Leg length: eXtra long Hip width: Medium
CYBERDYNE, INC.
HAL-ML05-DXMUS
In Commercial Distribution

  • 04560340090971 ()


  • Neuro-controlled ambulation exoskeleton

HAL for Medical Use - 04560340090964

Number of legs: Double Leg length: Long Hip width: Medium
CYBERDYNE, INC.
HAL-ML05-DLMUS
In Commercial Distribution

  • 04560340090964 ()


  • Neuro-controlled ambulation exoskeleton

HAL for Medical Use - 04560340090957

Number of legs: Double Leg length: Medium Hip width: Medium
CYBERDYNE, INC.
HAL-ML05-DMMUS
In Commercial Distribution

  • 04560340090957 ()


  • Neuro-controlled ambulation exoskeleton

HAL for Medical Use - 04560340090940

Number of legs: Double Leg length: Short Hip width: Medium
CYBERDYNE, INC.
HAL-ML05-DSMUS
In Commercial Distribution

  • 04560340090940 ()


  • Neuro-controlled ambulation exoskeleton

CODMAN - 10886704072881

Non-coring (Huber) Needle for use with CODMAN 3000 Series Drug Delivery System
Cerenovus, Inc.
AP-04009
Not in Commercial Distribution

  • 20886704072888 ()
  • 10886704072881 ()
AP04009

  • Implantable intrathecal infusion pump, nonprogrammable

CODMAN - 10886704044109

Models 400 and 550 Implantable Infusion Pump Refill Kit
Cerenovus, Inc.
IP-40820
Not in Commercial Distribution

  • 10886704044109 ()
IP40820

  • Implantable intrathecal infusion pump, nonprogrammable

CODMAN - 10886704044093

MODEL 400 REFILL TUBING SET
Cerenovus, Inc.
IP40812
Not in Commercial Distribution

  • 10886704044093 ()
IP40812

  • Implantable intrathecal infusion pump, nonprogrammable

CODMAN - 10886704043829

3000 Series High Temperature Drape for use with CODMAN O.R. Heater AP-09100
Cerenovus, Inc.
AP-09150
Not in Commercial Distribution

  • 20886704043826 ()
  • 10886704043829 ()
AP09150

  • Implantable intrathecal infusion pump, nonprogrammable

CODMAN - 10886704043621

Constant Flow Implantable Pump With Bolus Safety Valve and Operating Room Prep Kit
Cerenovus, Inc.
AP-03000UL
Not in Commercial Distribution

  • 10886704043621 ()
AP03000UL

  • Implantable intrathecal infusion pump, nonprogrammable

CODMAN - 10886704043614

Constant Flow Implantable Pump With Bolus Safety Valve and Operating Room Prep Kit
Cerenovus, Inc.
AP-03000M
Not in Commercial Distribution

  • 10886704043614 ()
AP03000M

  • Implantable intrathecal infusion pump, nonprogrammable

CODMAN - 10886704043607

Constant Flow Implantable Pump With Bolus Safety Valve and Operating Room Prep Kit
Cerenovus, Inc.
AP-03000L
Not in Commercial Distribution

  • 10886704043607 ()
AP03000L

  • Implantable intrathecal infusion pump, nonprogrammable

CODMAN - 10886704043591

Constant Flow Implantable Pump With Bolus Safety Valve and Operating Room Prep Kit
Cerenovus, Inc.
AP-03000H
Not in Commercial Distribution

  • 10886704043591 ()
AP03000H

  • Implantable intrathecal infusion pump, nonprogrammable

MEDSTREAM - 10886704071457

Refill Kit
Codman Neuro Sciences Sàrl
91-4285US
In Commercial Distribution

  • 20886704071454 ()
  • 10886704071457 ()
914285US

  • Implantable intrathecal infusion pump, programmable

NA - 10848584045459

ULPA/CHARCOAL FILTER CATRIDGES
Conmed Corporation
60-5902-001
Not in Commercial Distribution

  • 20848584045456 ()
  • 10848584045459 ()
  • 00848584045452 ()
60-5902-001

  • Surgical plume evacuation system

MINIVAC - 10845854053102

MiniVac Smoke Evacuation System 220-240V 50/60 Hz
Conmed Corporation
ECVV220
Not in Commercial Distribution

ECVV220

  • Surgical plume evacuation system

MINIVAC - 10845854053096

MiniVac Smoke Evacuation System 100V-120V 50/60 Hz
Conmed Corporation
ECVV120
In Commercial Distribution

  • 10614559104422 ()
  • 10845854053096 ()
  • 30845854053090 ()
ECVV120

  • Surgical plume evacuation 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

NA - 10653405005179

CABLE/STRAIN REL. BLACK
Conmed Corporation
711-7760
In Commercial Distribution

  • 10653405005179 ()
711-7760

  • Surgical plume evacuation system

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
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