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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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Cardiac Tube Holder
ORANGE SURGICAL INSTRUMENTS, LLC
OSCVORTH
In Commercial Distribution

  • B354OSCVORTH0 ()


  • Tissue extraction bag
  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Insufflation gas conditioning tubing set
  • Laparoscopic wound closure thread
The LifeWarmer Quantum Thermal Transfusion Set- Blood is the revolutionary IV tubing set that allows for safe, rapid warming of blood, blood products, or IV fluids without adding hardly any additional steps to the normal IV setup process. Modeled after standard blood infusion tubing, the familiar configuration allows for ease of use. The sophisticated intelligence and proprietary warming technology are integrated into the tubing system for simplicity and to reduce additional equipment and procedural steps. Roughly the same size and weight as standard blood tubing, there is almost no additional equipment burden. The Quantum IV administration tubing is double-extruded to yield a configuration that has both an inner tubing layer and an outer tubing layer. A conductive heating element is between the two layers but does not come in contact with the fluid path or disrupt the laminar flow. The outer tubing layer acts as an insulator while the inner tubing layer transfers the heat from the heating element to the fluid path. Thermistors (thermal resistors) located in the tubing continually measure temperature and provide that input to the Quantum Controller. The monitoring and independent application of energy (heat) along the fluid path allows the Quantum to respond to varying temperature inputs from the fluid source to near the point of patient entry to ensure fluid temperature is the right temperature at delivery. The Quantum Life Warmer, fully charged, is able to warm and maintain up to 2 units ( 900mL +/- 100mL) of cold (4C) blood products or IV solutions to a pre-set temperature of 100.4F (38+/- 2C) at a flow rate of 100 mL/min (depending on the ambient temperature). Or, approximately 1700 mL of 20C IV solution to a set point of 38C +/- 2C at a flow rate of 200 mL/min. Effective warming flow rates range from 2 to 200 mL/minute depending on input fluid temperature and ambient conditions.
NORTH AMERICAN RESCUE, LLC
63-5904
In Commercial Distribution

  • 00868058000454 ()
  • 00868058000416 ()
35-0005

  • Conduction blood/fluid warmer set
INSTRUMENT 6905782 ROD BENDER
MEDTRONIC SOFAMOR DANEK, INC.
6905782
In Commercial Distribution

  • 00681490886499 ()


  • Manual orthopaedic bender, reusable
INSTRUMENT 6905774 ROD HOLDER
MEDTRONIC SOFAMOR DANEK, INC.
6905774
In Commercial Distribution

  • 00681490886406 ()


  • Manual orthopaedic bender, reusable
INSTRUMENT 8796071 PLATE BENDER
MEDTRONIC SOFAMOR DANEK, INC.
8796071
In Commercial Distribution

  • 00673978955339 ()


  • Manual orthopaedic bender, reusable
No Description
Lazurite Holdings LLC
AF0013-101-11
In Commercial Distribution

  • 00860001744255 ()


  • Video camera surgical microscope system
Single-use foam block for use with HypoHolder system
TyTek Medical Inc.
1000
In Commercial Distribution

  • 00860013471606 ()


  • Surgical instrument interim-placement holder, single-use
The GI Windows Titanium Grasper is a surgical laparoscopic grasper with a non-ferrous distal actuator that is intended to be used with GIW’s Self-Forming Magnet (SFM) technology. The grasper’s form factor, handle, length, and actuation will be nearly identical to commercially available laparoscopic graspers that we used every day in the operating room. The primary differentiator of this product will be the titanium distal actuator, which due to its non-ferrous make up, will not create (or minimally create) a magnetic attraction force to the SFM implants while in use in surgery.
G.I. Windows, Inc.
200123
In Commercial Distribution

  • 00860012315505 ()


  • Surgical soft-tissue manipulation forceps, scissors-like, reusable
Fiber optic light carrier for surgical illumination through endoscope. Connects to Light cable.
Endocraft, LLC
UMG105-LCN
In Commercial Distribution

  • 00860009975187 ()
UMG105-LCN

  • Fibreoptic operating light system
The Caldera Medical Benesta Sterilization Tray is intended to enclose, protect, and organize the Caldera Medical Benesta Rod Lens Hysteroscope and accessories during sterilization and storage. Does not include accessory caddy.
Caldera Medical, Inc.
CAL-TR131
In Commercial Distribution

  • 00857492008133 ()


  • Device sterilization/disinfection container, reusable
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