TriPort15

Primary DI
05391530440097
Brand
TriPort15
Company
ADVANCED SURGICAL CONCEPTS LIMITED
Model
WA58015T
Device description
This device is intended for use as an endoscopic instrument(s) and/or camera port during minimally invasive abdominal surgery.The ASC TriPort15 is a sterile, disposable endoscopic multi-instrument port. The device consists of the following:• An Introducer that allows the insertion of the Base Retractor into the abdomen through an incision.• A Base Retractor that retracts in an abdominal incision to allow laparoscopic instruments pass through to the abdomen. • A Boot contains three instrument valves and two ports that allow insufflation of the abdomen or venting of electrocautery gases. The Boot maintains pneumoperitoneum when attached and allows specimen removal when detached.
Published
2016-09-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K111407000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111407000TRIPORT, TRIPORT+, TRIPORT15, QUADPORTAdvanced Surgical Concepts2012-01-18OTJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391530440080PackageGS15In Commercial Distribution
05391530440097PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391530440080053915304400805391530440080
05391530440097053915304400975391530440097

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
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

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
05391530440103QuadPort+WA58010Q2016-09-13

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
05391530440103QuadPort+ADVANCED SURGICAL CONCEPTS LIMITEDOTJ2016-09-13