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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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Electrode Delivery Tool Kit MedCoat, CE - 00852184003373

No Description
Synapse Biomedical, Inc.
22-0018
In Commercial Distribution

  • 00852184003373 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

Silicone Adhesive Kit - 00852184003359

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

  • 00852184003359 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

Connector Holder Kit - 00852184003342

No Description
Synapse Biomedical, Inc.
22-0004
In Commercial Distribution

  • 00852184003342 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation 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

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

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, SCI HDE, US - 00852184003298

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

  • 00852184003298 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

System Kit, ALS HDE - 00852184003281

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

  • 00852184003281 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

Anode Replacement Parts Kit - 00852184003274

No Description
Synapse Biomedical, Inc.
20-0043
In Commercial Distribution

  • 00852184003274 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

Spare Surgical Kit - 00852184003267

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

  • 00852184003267 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

NeuRx DPS™ Surgical Site Start-up Kit, SCI HDE - 00852184003199

No Description
Synapse Biomedical, Inc.
20-0007
In Commercial Distribution

  • 00852184003199 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

NeuRx DPS™ Surgical Site Start-up Kit - 00852184003083

No Description
Synapse Biomedical, Inc.
20-0039
In Commercial Distribution

  • 00852184003083 ()


  • 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, CE 2 EPG - 00852184003069

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

  • 00852184003069 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

NeuRx DPS™ Patient Kit, 1 EPG - 00852184003052

No Description
Synapse Biomedical, Inc.
20-0046
In Commercial Distribution

  • 00852184003052 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

NeuRx DPS Patient Kit - 00852184003045

No Description
Synapse Biomedical, Inc.
20-0036
In Commercial Distribution

  • 00852184003045 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

NeuRx DPS™ System Kit, ALS CE - 00852184003021

No Description
Synapse Biomedical, Inc.
20-0031
In Commercial Distribution

  • 00852184003021 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

NeuRx DPS™ System Kit - 00852184003014

No Description
Synapse Biomedical, Inc.
20-0030
In Commercial Distribution

  • 00852184003014 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

NA - 10705034732350

GRAFT PACKING BLOCK
Synthes GmbH
03.841.055
In Commercial Distribution

  • 07611819473140 ()
  • H981038410550 ()
  • 10705034732350 ()
03841055

  • Bone graft packing block

SynCage - 10705034732046

GRAFT PACKING BLOCK-MEDIUM FOR SYNCAGE EVOLUTION
Synthes GmbH
03.825.073
In Commercial Distribution

  • 07611819534773 ()
  • H981038250730 ()
  • 10705034732046 ()
03825073

  • Bone graft packing block

SynCage - 10705034732039

GRAFT PACKING BLOCK-SMALL FOR SYNCAGE EVOLUTION
Synthes GmbH
03.825.072
In Commercial Distribution

  • 07611819534766 ()
  • H981038250720 ()
  • 10705034732039 ()
03825072

  • Bone graft packing block

Zero-P VA - 10705034720838

PACKING BLOCK FOR ZERO-P VA IMPLANTS
Synthes GmbH
03.647.984
In Commercial Distribution

  • 07611819404502 ()
  • H981036479840 ()
  • 10705034720838 ()
03647984

  • Bone graft packing block

NA - 10705034717388

PACKING BLOCK FOR ZERO-P IMPLANTS
Synthes GmbH
03.617.984
In Commercial Distribution

  • 07611819969780 ()
  • H981036179840 ()
  • 10705034717388 ()
03617984

  • Bone graft packing block

SYNFIX Evolution - 10705034814193

SYNFIX® EVOLUTION IMPLANT PACKING STATION
Synthes GmbH
03.835.050
In Commercial Distribution

  • 07611819658172 ()
  • H981038350500 ()
  • 10705034814193 ()
03835050

  • Bone graft packing block

SynCage - 10705034732053

GRAFT PACKING BLOCK-LARGE FOR SYNCAGE EVOLUTION
Synthes GmbH
03.825.074
In Commercial Distribution

  • 07611819534780 ()
  • H981038250740 ()
  • 10705034732053 ()
03825074

  • Bone graft packing block

NA - 10705034778204

ACF GRAFT PACKING BLOCK
Synthes GmbH
396.996
In Commercial Distribution

  • H9813969960 ()
  • 10705034778204 ()
396996

  • Bone graft packing block

ALIF - 10705034774800

ALIF GRAFT PACKING BLOCK
Synthes GmbH
389.155
In Commercial Distribution

  • H9813891550 ()
  • 10705034774800 ()
389155

  • Bone graft packing block

BioRef-DC - 07290017249049

BIOFEEDBACK DEVICE BioRef-DC
TAVGER LTD
FG00019
In Commercial Distribution

  • 07290017249049 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

LEG-UP - 05050962080065

LEG-UP
THE HELPING HAND COMPANY (LEDBURY) LIMITED
LEG-UP YELLOW 26IN
In Commercial Distribution

  • 05050962080065 ()
HA0965

  • Movement-resistance gait rehabilitation device

LEG-UP - 05050962023048

LEG-UP
THE HELPING HAND COMPANY (LEDBURY) LIMITED
LEG-UP BLACK 26IN
In Commercial Distribution

  • 05050962023048 ()
HA0970

  • Movement-resistance gait rehabilitation device

Titan - 00817914024905

Iris Straight Bipolar Forcep 3 1/2" (88.9mm) Insulated With A (High Polished 10mm Long Area) With A 0.5mm Tip Country Of Origin USA
TITAN MANUFACTURING INC
160818205030101
In Commercial Distribution

  • 00817914024905 ()


  • Open-surgery electrosurgical handpiece/electrode, bipolar, reusable

Titan - 00817914024882

Yasargil Bayonet Bipolar Forcep 7 7/8" (200.03mm) Insulated With A (High Polished 10mm Long Area) With A 1.3mm Tip Anti-Stick Country of Origin: USA
TITAN MANUFACTURING INC
163128240070101
In Commercial Distribution

  • 00817914024882 ()

  • Length: 200.03 Millimeter


  • Open-surgery electrosurgical handpiece/electrode, bipolar, reusable

Titan - 00817914024875

Blue Titanium Square Grip Handle Bayonet Bipolar Forcep 8 3/4" (222.25mm) Insulated With A (High Polished 10mm Long Area) With A 1.5mm Tip, Anti-Stick Country of Origin: USA
TITAN MANUFACTURING INC
183928147080101
In Commercial Distribution

  • 00817914024875 ()

  • Length: 222.25 Millimeter


  • Open-surgery electrosurgical handpiece/electrode, bipolar, reusable

ENDOSKELETON® TCS - 00191375028345

Graft Packing & Screw Reference Block
TITAN SPINE, LLC
5210-1017
Not in Commercial Distribution

  • 00191375028345 ()

  • Height: 1 Inch
  • Width: 2 Inch
  • Length: 1.5 Inch
5210-1017

  • Bone graft packing block

ENDOSKELETON® TAS - 00191375028338

Graft Packing & Screw Reference Block
TITAN SPINE, LLC
2300-1317
Not in Commercial Distribution

  • 00191375028338 ()

  • Width: 1.5 Inch
  • Length: 2 Inch
  • Height: 1.25 Inch
2300-1317

  • Bone graft packing block

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

FILTRESSE - H671SSE2000

Smoke Filtration System (230 Volts AC)
UTAH MEDICAL PRODUCTS, INC.
230VAC
In Commercial Distribution

  • H671SSE2000 ()
SSE-200

  • Surgical plume evacuation system

FILTRESSE - H671SSE1000

Smoke Filtration System (115 Volts AC)
UTAH MEDICAL PRODUCTS, INC.
115VAC
In Commercial Distribution

  • H671SSE1000 ()
SSE-100

  • Surgical plume evacuation system

Epicel (cultured epidermal autografts) - W41020AU201S1969

Epicel (cultured epidermal autografts) is an aseptically processed wound dressing composed of the patient’s own (autologous) keratinocytes grown ex vivo in the presence of proliferation-arrested, murine (mouse) fibroblasts. Epicel consists of sheets of proliferative, autologous keratinocytes, ranging from 2 to 8 cell layers thick and is referred to as a cultured epidermal autograft. Each graft of Epicel is attached to petrolatum gauze backing with titanium surgical clips and measures a minimum of 50 cm2 in area. Epicel is authorized by Federal law for use in adult and pediatric patients who have deep dermal or full-thickness burns comprising a total body surface area greater than or equal to 30%. Epicel may be used in conjunction with split-thickness autografts, or alone in patients for whom split-thickness autografts may not be an option due to the severity and extent of their burns.
VERICEL CORPORATION
N/A
In Commercial Distribution

  • W41020AU201S1969 ()

  • Area/Surface Area: 50 Square centimeter


  • Cultured skin autograft/xenograft

Epicel (cultured epidermal autografts) - W41020AU201P0001

Epicel (cultured epidermal autografts) is an aseptically processed wound dressing composed of the patient’s own (autologous) keratinocytes grown ex vivo in the presence of proliferation-arrested, murine (mouse) fibroblasts. Epicel consists of sheets of proliferative, autologous keratinocytes, ranging from 2 to 8 cell layers thick and is referred to as a cultured epidermal autograft. Each graft of Epicel is attached to petrolatum gauze backing with titanium surgical clips and measures approximately 50 cm2 in area. Epicel is authorized by Federal law for use in adult and pediatric patients who have deep dermal or full-thickness burns comprising a total body surface area greater than or equal to 30%. Epicel may be used in conjunction with split-thickness autografts, or alone in patients for whom split-thickness autografts may not be an option due to the severity and extent of their burns.
VERICEL CORPORATION
0
In Commercial Distribution

  • W41020AU201P0001 ()

  • Area/Surface Area: 50 Square centimeter


  • Cultured skin autograft/xenograft

Activator - 08625630003010

Magnetic remote control for operation of inFlow urinary prosthesis. With base station and recharger.
VESIFLO INC
Sep 2016
Not in Commercial Distribution

  • 08625630003010 ()
403507

  • Intraurethral valve/pump

Activator - 08625630003001

Magnetic remote control for operation of inFlow urinary prosthesis. With base station and recharger.
VESIFLO INC
Sep 2016
Not in Commercial Distribution

  • 08625630003001 ()
403507

  • Intraurethral valve/pump

Magnetic Shield - 00862563003191

Magnetic shield for the inFlow Activator
VESIFLO INC
August 2021
In Commercial Distribution

  • 00862563003191 ()
403350

  • Intraurethral valve/pump

Activator Kit - 00862563003184

Magnetic remote control for the inFlow Device - with base station and medical charger
VESIFLO INC
August 2021
In Commercial Distribution

  • 00862563003184 ()
403507K

  • Intraurethral valve/pump

Medical Charger - 00862563003177

Recharger for inFlow Activator
VESIFLO INC
August 2021
In Commercial Distribution

  • 00862563003177 ()
403320

  • Intraurethral valve/pump

Base Station - 00862563003160

Unit for storing and recharging the inFlow Activator
VESIFLO INC
August 2021
In Commercial Distribution

  • 00862563003160 ()
403310

  • Intraurethral valve/pump

Activator - 00862563003153

Magnetic remote control for the inFlow Device
VESIFLO INC
August 2021
In Commercial Distribution

  • 00862563003153 ()
403300

  • Intraurethral valve/pump
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