Duns Number:989586482
Device Description: The PneumoLiner device is intended for use as a multiple instrument port and tissue contai 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. 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; and2. A laparoscopic multi-instrument port.1. Multi-instrument PortThe 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. PneumoLinerThe 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.
Catalog Number
-
Brand Name
PneumoLiner
Version/Model Number
WA90500US
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
DEN150028,DEN150028
Product Code
PMU
Product Code Name
Containment System, Laparoscopic Power Morcellation, With Instrument Port
Public Device Record Key
41657aa5-937e-427a-93f0-bee87c2a9b47
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 19, 2016
Package DI Number
05391530440011
Quantity per Package
5
Contains DI Package
05391530440004
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CARTON OF 5
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 4 |