PneumoLiner

Primary DI
05391530440011
Brand
PneumoLiner
Company
ADVANCED SURGICAL CONCEPTS LIMITED
Model
WA90500US
Device description
The PneumoLiner device is intended for use as a multiple instrument port and tissue containment system during minimally invasive gynecologic laparosco
Published
2016-09-19
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
PMUContainment System, Laparoscopic Power Morcellation, With Instrument Port

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PMUContainment System, Laparoscopic Power Morcellation, With Instrument PortObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN150028000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN150028000PneumoLinerAdvanced Surgical Concepts, Ltd.2016-04-07PMU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391530440011PackageGS15In Commercial Distribution
05391530440004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391530440011053915304400115391530440011
05391530440004053915304400045391530440004

GMDN Terms#

Term, Definition table
TermDefinition
Tissue extraction bagAn 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+35312864777info@advancedsurgical.ie

Regulatory Flags#

DUNS number
989586482
Device count
1
DM exempt
false
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
05391530440004PneumoLinerWA90500US2016-09-19
05391530440127GuardeniaGAR-12021-12-09
05391530440134GuardeniaGAR-12021-12-09
05391530440073TriPort+WA58010T2016-09-13
05391530440110QuadPort+WA58010Q2016-09-13
05391530440066TriPort+WA58010T2016-09-13
05391530440097TriPort15WA58015T2016-09-13
05391530440103QuadPort+WA58010Q2016-09-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290118830023LapBox PowerARK SURGICAL LTDPMU2025-06-17
EAMIMCS55310More-Cell BagAMI Agency for Medical Innovations GmbHPMU2021-12-09
EAMIMCS55510More-Cell-System 30AMI Agency for Medical Innovations GmbHPMU2021-12-09
EAMIMCS55110More-Cell-SystemAMI Agency for Medical Innovations GmbHPMU2021-12-09
EAMIMCS55311More-Cell BagAMI Agency for Medical Innovations GmbHPMU2021-12-09
MCS55511More-Cell-System 30AMI Agency for Medical Innovations GmbHPMU2021-12-09
05391530440004PneumoLinerADVANCED SURGICAL CONCEPTS LIMITEDPMU2016-09-19