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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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Pump Flow Probe
TRANSMEDICS, INC.
1426
In Commercial Distribution

  • B00925733 ()
  • B00925731 ()

  • Height: 2.3 Inch
  • Width: 5.13 Inch
  • Length: 9 Inch
1426

  • Extracorporeal fluid flow probe
OCS Regulator Yoke Gasket
TRANSMEDICS, INC.
1423
In Commercial Distribution

  • B00954003 ()
  • B00925681 ()

  • Height: 0.08 Inch
  • Width: 0.6 Inch
  • Length: 0.6 Inch
1423

  • Gas/fluid regulator gasket
OCS Mobile Base
TRANSMEDICS, INC.
1411
In Commercial Distribution

  • B00925711 ()
  • B00913320 ()

  • Height: 10 Inch
  • Width: 28 Inch
  • Length: 21 Inch
1411

  • Utility trolley
OCS Battery
TRANSMEDICS, INC.
1408
In Commercial Distribution

  • B00912501 ()
  • B00912500 ()

  • Height: 3 Inch
  • Width: 2 Inch
  • Length: 10 Inch
1408

  • Portable/mobile rechargeable battery pack
The device is indicated for extracorporeal shock wave treatment.
Storz Medical AG
SD1 T-Top
In Commercial Distribution

  • 07630039101398 ()
21362.0102

  • Electromechanical orthopaedic extracorporeal shock wave/pneumatic pressure wave therapy system
  • Dermatological extracorporeal shock wave therapy system
OCS Power Cord, North America
TRANSMEDICS, INC.
1432
In Commercial Distribution

  • B00954033 ()
  • B00914051 ()

  • Height: 2 Inch
  • Width: 10 Inch
  • Length: 8 Inch
1432

  • Electrical mains power cable
The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant designed to occlude airflow in the target lobe and thereby reduce lung volume. The device consists of a one-way silicone duckbill valve attached to a nickel-titanium (Nitinol) self-expanding retainer that is covered with a silicone membrane. It is implanted in the target bronchus during a bronchoscopy procedure using the Zephyr Endobronchial Delivery Catheter (EDC) that is guided to the targeted bronchus by inserting it through the working channel of an adult bronchoscope. Successful lobar occlusion may require placement of multiple Zephyr Valves in bronchi of the target lobe. The Zephyr Valves permit air to vent out of the treated lobe during exhalation but do not permit refilling of this region during inhalation to reduce hyperinflation due to emphysema. Trapped air in the diseased lobe escapes through the Zephyr Valves until the lung volume of the treated lobe is reduced. The Zephyr Valve is designed to be a permanent implant, but can be removed, if necessary.
PULMONX CORPORATION
EBV-TS-4.0-LP
In Commercial Distribution

  • 00811907030225 ()

  • Bronchial Diameter Range 4.0-7.0 mm


  • Endobronchial valve
Irrigation Pump
Biosense Webster Inc
D139702
In Commercial Distribution

  • 10846835017472 ()
D139702

  • Cardiac radio-frequency ablation system generator
The Catheter Revision Kit is a sterile kit designed to facilitate the replacement of a section of the intrathecal catheter. A replacement catheter segment is provided with a catheter connector (and sleeve) to allow this segment to be attached to the existing catheter.
Flowonix Medical, Inc.
11830
In Commercial Distribution

  • 00810335020105 ()


  • Spinal infusion/drainage catheter
"One box of RHA® 2 contains two blisters and one instruction for use. Each blister contains a 1mL prefilled syringe and two needles (30G 1/2). Box Packaging (ID 07640173234111) is defined as unit of sales and identified with a serial number."
Teoxane SA
RHA® 2 - Terumo - US
In Commercial Distribution

  • 07640173234111 ()
  • 07640173234128 ()
940103

  • Dermal tissue reconstructive material, microbe-derived, anaesthetic
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