AccessGUDID - DEVICE: TriPort+ (05391530440073)

GUDID

Device Identifier (DI) Information

Brand Name: TriPort+
Version or Model: WA58010T
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ADVANCED SURGICAL CONCEPTS LIMITED

Primary DI Number: 05391530440073
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 989586482 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OTJ	Laparoscopic Single Port Access Device
GCJ	Laparoscope, General & Plastic Surgery

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K110004	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f6f5d140-0aa9-4464-a454-8ef5488dabc8
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 13, 2016