QuadPort+

Primary DI
05391530440103
Brand
QuadPort+
Company
ADVANCED SURGICAL CONCEPTS LIMITED
Model
WA58010Q
Device description
This device is intended for use as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery. The ASC QuadPort
Published
2016-09-13
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
OTJLaparoscopic Single Port Access Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OTJLaparoscopic Single Port Access DeviceGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121309000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121309000ASC QUADPORT + LAPAROSCOPIC ACCESS DEVICEAdvanced Surgical Concepts2012-09-06OTJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391530440103PackageGS13In Commercial Distribution
05391530440110PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391530440103053915304401035391530440103
05391530440110053915304401105391530440110

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic multi-instrument access port, single-useA sterile sleeve assembly made of plastic materials intended to retract a small abdominal incision to allow multiple laparoscopic instruments to pass into the abdomen at the same time during a laparoscopic procedure. It will typically have an introducer that creates the abdominal incision (but is not used in cases where the surgeon chooses to make the incision), and a valve component that maintains the pneumoperitoneum established for the surgical procedure. It allows for the introduction of multiple instruments and/or a camera port, and removal of larger specimens during minimally-invasive laparoscopic surgery. 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
05391530440011PneumoLinerWA90500US2016-09-19
05391530440066TriPort+WA58010T2016-09-13
05391530440097TriPort15WA58015T2016-09-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04055207007808NARichard Wolf GmbHOTJ2024-08-19
04055207069912NARichard Wolf GmbHOTJ2024-08-19
08719324463188symphonX™Fortimedix Surgical B.V.OTJ2019-05-22
08719324463195symphonX™Fortimedix Surgical B.V.OTJ2019-05-22
08719324463201symphonX™Fortimedix Surgical B.V.OTJ2019-05-22
04055207021088NARichard Wolf GmbHOTJ2018-09-24
08719324463171symphonX™Fortimedix Surgical B.V.OTJ2017-02-15
08719324463003symphonX™Fortimedix Surgical B.V.OTJ2017-02-15
08719324463072symphonX™Fortimedix Surgical B.V.OTJ2017-02-15
04055207011331NARichard Wolf GmbHOTJ2016-10-07
04055207011348NARichard Wolf GmbHOTJ2016-10-07
04055207011324NARichard Wolf GmbHOTJ2016-09-30
04055207021071KEYPORTRichard Wolf GmbHOTJ2016-09-26
04055207011355KEYPORTRichard Wolf GmbHOTJ2016-09-23
04055207011362KEYPORTRichard Wolf GmbHOTJ2016-09-23
04055207011379KEYPORTRichard Wolf GmbHOTJ2016-09-23
04055207011386KEYPORTRichard Wolf GmbHOTJ2016-09-23
04055207021057NARichard Wolf GmbHOTJ2016-09-23
04055207021064NARichard Wolf GmbHOTJ2016-09-23
05391530440073TriPort+ADVANCED SURGICAL CONCEPTS LIMITEDOTJ2016-09-13
05391530440110QuadPort+ADVANCED SURGICAL CONCEPTS LIMITEDOTJ2016-09-13
05391530440066TriPort+ADVANCED SURGICAL CONCEPTS LIMITEDOTJ2016-09-13
05391530440097TriPort15ADVANCED SURGICAL CONCEPTS LIMITEDOTJ2016-09-13