Pall LaparoShield® Plus Laparoscopic Smoke Filtration System - Laparoscopic Smoke Filtration System - Pall International Sàrl

Duns Number:485050483

Device Description: Laparoscopic Smoke Filtration System

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More Product Details

Catalog Number

LSF1

Brand Name

Pall LaparoShield® Plus Laparoscopic Smoke Filtration System

Version/Model Number

LSF1

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

-

Product Code Details

Product Code

FYD

Product Code Name

APPARATUS, EXHAUST, SURGICAL

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

Additional Identifiers

Package DI Number

35034480308970

Quantity per Package

10

Contains DI Package

05034480308979

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case

"PALL INTERNATIONAL SÀRL" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 18