symphonX™

Basic Information

• Brand Name: symphonX™
• Primary DI: 08719324463102
• Version / Model: Handle with on/off ratchet
• Catalog Number: 314-303
• 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: 2018-11-28
• Public Version: 5
• Public Version Date: 2020-09-14
• Public Version Status: Update
• Public Device Record Key: 5b6fb78a-0dfb-4ee7-bdb2-55deccbcf9e1
• Distribution End Date: 2020-09-10

Device Description

The symphonX™ Handle with on/off ratchet is for use in combination with the symphonX™ Instruments of the types: Grasper (short), Maryland (short), Scissors (short) and Clip Applier (short).

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: 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
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47829	Surgical instrument handle, non-torque-limiting	A hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08719324463102	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