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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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Thermometer, colour-indicating
ONE POWER
DR-TZ-US2
In Commercial Distribution

  • 08800105200020 ()
  • 18800105200027 ()


  • Colour-indication patient thermometer
Electrosurgical Handpiece
Med Pen Concepts LLC
Plasma+
In Commercial Distribution

  • 00860010385616 ()


  • Electrosurgical handpiece, reusable
Electrosurgical Handpiece
Med Pen Concepts LLC
PlasmaMD
In Commercial Distribution

  • 00860010385609 ()


  • Electrosurgical handpiece, reusable
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
Electrosurgical Handpiece
Med Pen Concepts LLC
Plasma+
In Commercial Distribution

  • 08600103856027 ()
CS-100002

  • Electrosurgical handpiece, reusable
Electrosurgical Handpiece
Med Pen Concepts LLC
PlasmaMD
In Commercial Distribution

  • 08600103856010 ()
CS-100001

  • Electrosurgical handpiece, reusable
No Description
GCS Co., Ltd.
GPX-2000
In Commercial Distribution

  • 08809581025837 ()


  • Electrosurgical handpiece, reusable
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
More-Cell Bag is intended for use as a tissue containment system during minimally invasive gynecologic laparoscopic surgery to enable the isolation and containment of tissue considered benign, resected during multi-site laparoscopic surgery for power morcellation and removal.
AMI Agency for Medical Innovations GmbH
MCS5531
In Commercial Distribution

  • EAMIMCS55311 ()
  • EAMIMCS55310 ()
MCS5531

  • Tissue extraction bag
More-Cell-System is intended for use as a tissue containment system during minimally invasive gynecologic laparoscopic surgery to enable the isolation and containment of tissue considered benign, resected during multi-site laparoscopic surgery for power morcellation and removal.
AMI Agency for Medical Innovations GmbH
MCS5511
In Commercial Distribution

  • EAMIMCS55110 ()
  • MCS55111 ()
MCS5511

  • Tissue extraction bag
The LapBox Power Contained Tissue Extraction System is a single use sterile device. It is comprised of a double wall inflatable polyurethane chamber which is mounted on an insertion shaft and is provided with two port sizes. Once the shaft is inserted to the abdominal cavity, the chamber is deployed and the organ to be morcellated is placed within the chamber. The chamber is then inflated using an external handpump and the sleeve of the chamber is exteriorized. The selected port is then placed over the sleeve in the incision site and the organ can be power morcellated. Once morcellation is complete, the port is removed, and the chamber is deflated and removed from the patient.
ARK SURGICAL LTD
ARK-P01
In Commercial Distribution

  • 07290118830023 ()
  • 07290118830030 ()


  • Tissue extraction bag
No Description
Shenzhen Leaflife Technology Co., Ltd.
LE-EPSMC
In Commercial Distribution

  • 06974223650073 ()


  • Electrosurgical handpiece, single-use
Power Cord
Macan Manufacturing
1.096
In Commercial Distribution

  • 00851708006630 ()


  • Electrosurgical system
Power Cannula
Innovative Med
Power Cannula
In Commercial Distribution

  • 00851314007069 ()
IM-MAST-LIP

  • Liposuction system cannula, reusable
  • Liposuction system
Power Supply
ST. JUDE MEDICAL, INC.
H700980
In Commercial Distribution

  • 05415067009807 ()
H700980

  • Cardiac mapping system
Power Supply
ST. JUDE MEDICAL, INC.
H700979
In Commercial Distribution

  • 05415067009791 ()
H700979

  • Cardiac mapping system
Power Cord
ST. JUDE MEDICAL, INC.
H700182
In Commercial Distribution

  • 05415067001825 ()
H700182

  • Electrical-only medical device connection cable, reusable
Power Supply
ST. JUDE MEDICAL, INC.
CM1110
In Commercial Distribution

  • 05414734509916 ()
CM1110

  • Implantable pulmonary artery pressure monitoring system
Power Supply
ST. JUDE MEDICAL, INC.
CM3022
In Commercial Distribution

  • 05414734509312 ()
CM3022

  • Implantable pulmonary artery pressure monitoring system
POWER WHEEL
Power Dental U.S.A. Inc.
7820-4
In Commercial Distribution

  • D94378204 ()
7820-4

  • Dental amalgam carrier
  • Dental spatula, reusable
  • Steel dental bur, reusable
Power Supply
ST. JUDE MEDICAL, INC.
H701803
In Commercial Distribution

  • 05415067018038 ()
H701803

  • Electrical-only medical device connection cable, reusable
Power Module
Thoratec Corporation
1340
In Commercial Distribution

1340

  • Basic power supply, reusable
Power Cord
Microcube, LLC
4006
In Commercial Distribution

  • 00850044503155 ()


  • Microwave ablation system
Power Driver
SPINEOLOGY INC.
86-05-47
In Commercial Distribution

  • M7408600547 ()
860-0547

  • Metallic spinal interbody fusion cage
Power cord
META SYSTEMS CO., LTD.
WS001HWH
Not in Commercial Distribution

  • 08809455600467 ()


  • Endodontic obturation system
Power Cord
BOSTON SCIENTIFIC CORPORATION
M0067912000
In Commercial Distribution

  • 08714729874690 ()


  • Electrical mains power extension cable
Power Cord
BOSTON SCIENTIFIC CORPORATION
0136-1492
In Commercial Distribution

  • 08714729987000 ()


  • General/multiple surgical frequency-doubled solid-state laser system
Power switch
H ROBOTICS INC.
RHSW
In Commercial Distribution

  • 08800101600084 ()


  • Ankle continuous passive motion exerciser
  • Hand/wrist continuous passive motion exerciser
  • Continuous passive motion joint exerciser
Power Cord
HUOT INSTRUMENTS, LLC
PWC
In Commercial Distribution

  • M575PWC0 ()
PWC

  • Fixed examination/treatment room light
  • Mobile examination/treatment room light
Power Shell
Covidien LP
SIGPSHELL
In Commercial Distribution

  • 20884521543796 ()
  • 10884521543799 ()


  • Surgical stapler handpiece housing
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