FDA.reportPublic FDA data

Pall LaparoShield® Plus Laparoscopic Smoke Filter

Primary DI
35034480314148
Brand
Pall LaparoShield® Plus Laparoscopic Smoke Filter
Company
Pall International Sàrl
Model
LSF2
Catalog number
LSF2
Device description
Laparoscopic Smoke Filter
Published
2016-07-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FYDAPPARATUS, EXHAUST, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FYDApparatus, Exhaust, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
35034480314148PackageGS110In Commercial Distribution
05034480314147PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3503448031414835034480314148
05034480314147050344803141475034480314147

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic plume filterA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)645-6578QAMedical@pall.com

Regulatory Flags#

DUNS number
485050483
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05034480310125Pall PharmAssure® 25 mm Hydrophobic Vent FilterHP2002HP20022016-07-27
05034480000392Pall LeukoGuard LGLG6LG62015-10-21
05034480000408Pall LeukoGuard LGLG6BLG6B2015-10-21
05034480000446Pall® Oxygenator Gas Line FilterORO1HORO1H2016-07-20
05034480104373Pall Supor® AEF FilterAEF1EAEF1E2016-07-20
05034480306104Pall LeukoGuard BC2BC2BBC2B2015-10-21
05034480308825Pall Supor® AEF FilterAEF1NTEAEF1NTE2016-07-20
05034480308979Pall LaparoShield® Plus Laparoscopic Smoke Filtration SystemLSF1LSF12016-07-20
05034480309143Pall® Pro-Tec Filter for Pulmonary Function TestingPF30SPF30S2016-07-20
05034480310170Pall PharmAssure® Syringe FilterHP4648HP46482024-03-15
05034480313553Pall-Aquasafe™ Water FilterAQF4AAQF4A2016-07-20
05034480313690Pall-Aquasafe™ Water FilterAQ31F1SAAQ31F1SA2016-07-20
05034480313744Pall-Aquasafe™ Water FilterAQ31F1RAAQ31F1RA2016-07-20
05034480313751Pall-Aquasafe™ Water FilterAQINAAQINA2016-07-20
05034480314147Pall LaparoShield® Plus Laparoscopic Smoke FilterLSF2LSF22016-07-20
05034480314802Pall-Aquasafe™ Detachable Shower RoseAQROSEAAQROSEA2016-07-20
05034480315106Pall625418562541852015-10-21
05034480315502Pall QPoint® Filter CapsuleQJ22AQJ22A2017-12-20
05034480315519Pall QPoint® Filter CapsuleQJ212AQJ212A2017-12-20
05034480315526Pall QPoint® Filter CapsuleQR212AQR212A2017-12-20

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