AccessGUDID - DEVICE: Pall LaparoShield® Plus Laparoscopic Smoke Filtration System (05034480308979)

GUDID

Device Identifier (DI) Information

Brand Name: Pall LaparoShield® Plus Laparoscopic Smoke Filtration System
Version or Model: LSF1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: LSF1
Company Name: Pall International Sàrl

Primary DI Number: 05034480308979
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 485050483 *Terms of Use

Device Description: Laparoscopic Smoke Filtration System

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
60836	Laparoscopic plume filter	A sterile device intended to be used during minimally-invasive surgery, in particular laparoscopic surgery, to filter surgical smoke (plume created by, e.g., electrosurgical diathermy, a laser or sonic scalpel) of potentially harmful agents (e.g., noxious chemicals, particulates, viruses, bacteria) without loss of pneumoperitoneum. It is typically a multi-layered filter pouch intended to be connected to a trocar stopcock; it is intended to help protect surgical staff from ambient exposure to potentially harmful agents. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FYD	APPARATUS, EXHAUST, SURGICAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: >99.999% airborne particulate, bacterial and viral reduction efficiency

Device Record Status

Public Device Record Key: 80db2ef7-5a8e-45b4-8df3-a199bea87b11
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: July 20, 2016