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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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Power Bender
GLOBUS MEDICAL, INC.
634.506
In Commercial Distribution

  • 00849044065824 ()


  • Manual orthopaedic bender, reusable
Power Mix
WRIGHT MEDICAL TECHNOLOGY, INC.
876P0200
In Commercial Distribution

  • 00889797076036 ()

  • Total Volume: 20 Milliliter
876P0200

  • Bone matrix implant, human-derived
Power Mix
WRIGHT MEDICAL TECHNOLOGY, INC.
876P0040
In Commercial Distribution

  • 00889797076012 ()

  • Total Volume: 4 Milliliter
876P0040

  • Bone matrix implant, human-derived
Power Mix
WRIGHT MEDICAL TECHNOLOGY, INC.
876P0020
In Commercial Distribution

  • 00889797076005 ()

  • Total Volume: 2 Milliliter
876P0020

  • Bone matrix implant, human-derived
Power Bender
GLOBUS MEDICAL, INC.
6041.0506
In Commercial Distribution

  • 00889095167511 ()


  • Manual orthopaedic bender, reusable
Power Shell
Covidien LP
SIGPSHELL
In Commercial Distribution

  • 20884521543796 ()
  • 10884521543799 ()


  • Surgical stapler handpiece housing
Power Mix
WRIGHT MEDICAL TECHNOLOGY, INC.
876P0400
In Commercial Distribution

  • 00840420135162 ()

  • Total Volume: 4 Milliliter
876P0400

  • Bone matrix implant, synthetic, non-antimicrobial
Power Mix
WRIGHT MEDICAL TECHNOLOGY, INC.
876P2000
In Commercial Distribution

  • 00840420135155 ()

  • Total Volume: 20 Milliliter
876P2000

  • Bone matrix implant, synthetic, non-antimicrobial
The PneumoLiner device is intended for use as a multiple instrument port and tissue containment system during minimally invasive gynecologic laparoscopic surgery to enable the isolation and containment of tissue, considered benign, resected during single-port or multi-site laparoscopic surgery during power morcellation and removal. When used in women with fibroids, the PneumoLiner is for women who are pre-menopausal and under age 50. The PneumoLiner is compatible with bipolar or electromechanical laparoscopic power morcellators that are between 15mm and 18mm in shaft outer diameter and 135mm and 180mm in shaft working length and which have an external component that allows for the proper orientation of the laparoscope to perform a contained morcellation. The ASC PneumoLiner Device has two main components. It consists of: 1. The PneumoLiner, a tissue pouch intended to provide a space within the abdomen for the safe morcellation of tissue; and 2. A laparoscopic multi-instrument port. 1. Multi-instrument Port The laparoscopic multi-instrument port is comprised of the following three sub-components: The Retractor Introducer which delivers the Distal Ring of the Retractor through a premade incision, into the abdominal cavity. The Retractor which retracts an abdominal incision to allow the passage of laparoscopic instruments and provides an anchor for the Valve Component. The Boot Assembly which maintains the pneumoperitoneum established for the surgical procedure. 2. PneumoLiner The PneumoLiner, has two sub-components: An Introducer for delivery of the PneumoLiner. The PneumoLiner, that when under pneumoperitoneum provides a space for morcellation of the chosen tissue that can be visualized.
ADVANCED SURGICAL CONCEPTS LIMITED
WA90500US
In Commercial Distribution

  • 05391530440011 ()
  • 05391530440004 ()


  • Tissue extraction bag
More-Cell-System is intended for use as a tissue containment system during minimally invasive gynecologic laparoscopic surgeryto enable the isolation and containment of tissue considered benign, resected during multi-site laparoscopic surgery for powermorcellation and removal.
AMI Agency for Medical Innovations GmbH
MCS5551
In Commercial Distribution

  • MCS55511 ()
  • EAMIMCS55510 ()
MCS5551

  • Tissue extraction bag
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