PneumoLiner - The PneumoLiner device is intended for use as a - ADVANCED SURGICAL CONCEPTS LIMITED

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.

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More Product Details

Catalog Number

-

Brand Name

PneumoLiner

Version/Model Number

WA90500US

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

PMU

Product Code Name

Containment System, Laparoscopic Power Morcellation, With Instrument Port

Device Record Status

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

Additional Identifiers

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

"ADVANCED SURGICAL CONCEPTS LIMITED" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 4