YelloPort Elite - Laparoscopic Port Access System

Basic Information

• Brand Name: YelloPort Elite - Laparoscopic Port Access System
• Primary DI: 05051986012438
• Version / Model: ET1207503
• Company Name: SURGICAL INNOVATIONS LIMITED
• Labeler DUNS: 771051935
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-10-08
• Public Version: 1
• Public Version Date: 2020-10-16
• Public Version Status: New
• Public Device Record Key: f16fdf6b-ba8e-4fef-a0c6-eac1af450398

Device Description

12x75 Pencil Point Trocar

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• 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: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61424	Laparoscopic trocar blade, reusable	A rigid, surgical instrument with a sharp pyramidal or conical point intended to puncture the abdominal wall to facilitate the introduction of a separate laparoscopic access cannula (not included) during laparoscopy. It is intended to fill the lumen of the laparoscopic access cannula, whereby following puncture it is withdrawn to provide a single-lumen access port to the abdominal cavity. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05051986012438	GS1

Premarket Submissions

Submission Number	Supplement Number
K190592	000