symphonX™

Basic Information

• Brand Name: symphonX™
• Primary DI: 08719324463003
• Version / Model: Introducer
• Catalog Number: 314-101
• Company Name: Fortimedix Surgical B.V.
• Labeler DUNS: 492888563
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-02-15
• Public Version: 8
• Public Version Date: 2020-09-14
• Public Version Status: Update
• Public Device Record Key: b41a146f-0aa8-4bc3-8c80-f8ff116bd61d
• Distribution End Date: 2020-09-10

Device Description

The symphonX™ Introducer is intended to establish a path of entry for laparoscopic Instruments for use during minimally invasive abdominal laparoscopic surgery in combination with the symphonX™ (short) Instruments.

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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
OTJ	Laparoscopic Single Port Access Device	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62452	Laparoscopic multi-instrument access port, reusable	A multi-lumen sleeve assembly intended to retract a small abdominal incision to allow multiple laparoscopic instruments to access the abdominal cavity simultaneously through a single abdominal incision, during minimally-invasive laparoscopic surgery. It will include a valve component for each lumen that maintains the established pneumoperitoneum; the trocar used to create the abdominal incision might be included; it may include attached external instrument holding arms. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08719324463003	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 5 – 45 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 20 – 80 Percent (%) Relative Humidity