DEVICE: PneumoLiner (05391530440004)

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Device Identifier (DI) Information

PneumoLiner
WA90500US

ADVANCED SURGICAL CONCEPTS LIMITED
05391530440004
GS1
1
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; 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.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Tissue extraction bag An impervious, flexible, sterile container intended to be used during minimally-invasive, typically keyhole, surgical techniques (e.g., laparoscopic) to extract dissected patient body tissue. The device is inserted into the body through a large bore cannula port, and the tissue to be extracted is placed in the bag with trans-cannula instruments and evacuated through the cannula. The device typically includes an x-ray detectable thread. This device may be used for surgical interventions such as an appendectomy, colonectomy, lymphadenectomy, or gallbladder removal. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
PMU Containment System, Laparoscopic Power Morcellation, With Instrument Port
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
September 19, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
05391530440011 5 05391530440004 In Commercial Distribution CARTON OF 5
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+35312864777
info@advancedsurgical.ie
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