TriPort+

Basic Information

• Brand Name: TriPort+
• Primary DI: 05391530440073
• Version / Model: WA58010T
• Company Name: ADVANCED SURGICAL CONCEPTS LIMITED
• Labeler DUNS: 989586482
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-13
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: f6f5d140-0aa9-4464-a454-8ef5488dabc8

Device Description

This device is intended for use as an endoscopic instrument(s) and/or camera port during minimally invasive abdominal surgery. The ASC TriPort+ 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 four 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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OTJ	Laparoscopic Single Port Access Device	Gastroenterology, Urology	876.1500	2
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38456	Laparoscopic multi-instrument access port, single-use	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05391530440066	GS1	CARTON OF 5	5	In Commercial Distribution
Primary	05391530440073	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K110004	000