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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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remede System Flexible Programming Wand - 00857688007339

remede System Flexible Programming Wand
RESPICARDIA, INC.
1004A-F
In Commercial Distribution

  • 00857688007339 ()


  • Transvenous phrenic nerve electrical stimulation control unit

remede System External Pulse Generator - 00857688007346

remede System external pulse generator
RESPICARDIA, INC.
1006
In Commercial Distribution

  • 00857688007346 ()


  • Transvenous phrenic nerve electrical stimulation control unit

remede EL/EL-X External Pulse Generator - 00857688007414

remede EL/EL-X external pulse generator
RESPICARDIA, INC.
1006A
In Commercial Distribution

  • 00857688007414 ()


  • Transvenous phrenic nerve electrical stimulation control unit

remede EL-X System Implantable Pulse Generator Inline Connector - 00857688007407

remede EL-X System, implantable pulse generator for phrenic nerve stimulation, inline connector header
RESPICARDIA, INC.
1600
In Commercial Distribution

  • 00857688007407 ()


  • Transvenous phrenic nerve electrical stimulation control unit

remede EL System Implantable Pulse Generator IS-1 - 00857688007391

remede EL System, implantable pulse generator for phrenic nerve stimulation, IS-1 header
RESPICARDIA, INC.
1100
In Commercial Distribution

  • 00857688007391 ()


  • Transvenous phrenic nerve electrical stimulation control unit

remOVE FBR Set - 04260206310785

The remOVE FBR Set is a foreign body retrieval set for flexible endoscopy • safe removal of ingested foreign objects • it consists of the following products: remOVE SecureCap 12 (elastic and transparent retrieval cap) • remOVE Grasper (specially designed grasping forceps | alligator and rat teeth for strong hold and easy retrieval of foreign bodies into the remOVE Secure Cap)
Ovesco Endoscopy AG
12
In Commercial Distribution

  • 04260206310778 ()
  • 04260206310785 ()

  • for endoscope diameter 9.5 - 12 mm
  • working channel diameter 2.8 mm
  • working length 220 cm
400.05

  • Flexible endoscopic tissue manipulation forceps, single-use

remOVE DC Impulse - 04260206310563

The remOVE DC Impulse Generator is part of the remOVE System and is a medical electrical device for fragmentation of OTSC and FTRD clips made by Ovesco Endoscopy AG for the digestive tract • design ensures a direct pulse only when sufficient contact with a segment of the clip is established • required accessories for operating the remOVE DC Impulse are: DC Impulse generator | foot-activated switch with connector cable | power cord | DC cord in order to connect the DC Cutter (part of remOVE DC Cutter Set) • can only be used in combination with remOVE DC Cutter Set
Ovesco Endoscopy AG
400.01
In Commercial Distribution

  • 04260206310563 ()
400.01

  • Gastrointestinal endoscopic clip cutter generator

remOVE DC Cutter Set - 04260206310938

The remOVE DC Cutter Set 12 consists of the following products: remOVE DC Cutter is a bipolar endoscopic direct current (DC) instrument for fragmentation of OTSC and FTRD clips in the digestive tract • consists of an insulated conducting wire with an exposed tip • intended to conduct the direct current (DC) supplied by the remOVE DC Impulse to a previously implanted clip • separation of the clip through resistive heating • remOVE DC Cutter is designed to be used only with the remOVE DC Impulse and flexible endoscopes | remOVE SecureCap 12 is an elastic and transparent retrieval cap for safe extraction of the clip fragments | remOVE Grasper is a grasping forceps for retrieval of clip fragments into the remOVE SecureCap • for removal of these fragments out of the GI tract
Ovesco Endoscopy AG
12
In Commercial Distribution

  • 04260206310938 ()

  • for endoscopes diameter 9.5-12 mm
  • working length 220 cm
  • working channel diameter 2.8 mm
400.02.01s

  • Gastrointestinal endoscopic clip cutter
  • Endoscope tissue removal cap, single-use
  • Flexible endoscopic tissue manipulation forceps, single-use

remOVE DC Cutter Set - 04260206310921

The remOVE DC Cutter Set 14 is part of the remOVE System and consists of the following products: remOVE DC Cutter is a bipolar endoscopic direct current (DC) instrument for fragmentation of OTSC and FTRD clips in the digestive tract • consists of an insulated conducting wire with an exposed tip • intended to conduct the direct current (DC) supplied by the remOVE DC Impulse to a previously implanted clip • separation of the clip through resistive heating • remOVE DC Cutter is designed to be used only with the remOVE DC Impulse and flexible endoscopes | remOVE SecureCap 14 is an elastic and transparent retrieval cap for safe extraction of the clip fragments | remOVE Grasper is a grasping forceps for retrieval of clip fragments into the remOVE SecureCap • for removal of these fragments out of the GI tract
Ovesco Endoscopy AG
14
In Commercial Distribution

  • 04260206310921 ()

  • for endoscopes diameter 12-14 mm
  • working length 220 cm
  • working channel diameter 2.8 mm
400.02.02s

  • Flexible endoscopic tissue manipulation forceps, single-use
  • Endoscope tissue removal cap, single-use
  • Gastrointestinal endoscopic clip cutter

reliaFIL LC - 05060446604847

Uni LC Comp Caps 20x0.25 INC
ADVANCED HEALTHCARE LTD.
AH0961
In Commercial Distribution

  • 05060446604847 ()


  • Dental composite resin
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