symphonX™ 314-201

GUDID 08719324463072

Device for use in combination with the symphonX Introducer during minimally invasive abdominal laparoscopic surgical procedures

Fortimedix Surgical B.V.

Endoscope channel support kit Endoscope channel support kit Endoscope channel support kit Endoscope channel support kit Endoscope channel support kit Endoscope channel support kit Endoscope channel support kit Endoscope channel support kit Endoscope channel support kit Endoscope channel support kit Endoscope channel support kit Endoscope channel support kit Endoscope channel support kit Endoscope channel support kit Endoscope channel support kit

• Primary Device ID: 08719324463072
• NIH Device Record Key: 03c11ecb-75dc-4e79-b052-afb2ede30aa1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: symphonX™
• Version Model Number: Hub Cap & Sealing Unit
• Catalog Number: 314-201
• Company DUNS: 492888563
• Company Name: Fortimedix Surgical B.V.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +31454047470
• Email: saleseurope@fortimedix.com
• Phone: +31454047470
• Email: saleseurope@fortimedix.com
• Phone: +31454047470
• Email: saleseurope@fortimedix.com
• Phone: +31454047470
• Email: saleseurope@fortimedix.com
• Phone: +31454047470
• Email: saleseurope@fortimedix.com
• Phone: +31454047470
• Email: saleseurope@fortimedix.com
• Phone: +31454047470
• Email: saleseurope@fortimedix.com
• Phone: +31454047470
• Email: saleseurope@fortimedix.com
• Phone: +31454047470
• Email: saleseurope@fortimedix.com
• Phone: +31454047470
• Email: saleseurope@fortimedix.com
• Phone: +31454047470
• Email: saleseurope@fortimedix.com
• Phone: +31454047470
• Email: saleseurope@fortimedix.com
• Phone: +31454047470
• Email: saleseurope@fortimedix.com
• Phone: +31454047470
• Email: saleseurope@fortimedix.com
• Phone: +31454047470
• Email: saleseurope@fortimedix.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	08719324463072 [Package]; Contains: 08719324463171; Package: Carton box [12 Units]; In Commercial Distribution
GS1	08719324463171 [Primary]

FDA Product Code

• OTJ: Laparoscopic Single Port Access Device

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-11-15
• Device Publish Date: 2017-02-15

On-Brand Devices [symphonX™]

• 08719324463355: Device for cutting or coagulating tissue; to be used in combination with an electrosurgical gene
• 08719324463348: Device for use as a delivery system for Hem-o-lok® ML Non-absorbable Polymer Ligation Clips; to
• 08719324463331: Device for cutting tissue; to be used in combination with the symphonX Handle, Handle with ratch
• 08719324463324: Device for grasping and dissecting tissue; to be used in combination with the symphonX Handle, H
• 08719324463317: Device for grasping tissue; to be used in combination with the symphonX Handle, Handle with ratc
• 08719324463072: Device for use in combination with the symphonX Introducer during minimally invasive abdominal l
• 08719324463065: Device for irrigating/ aspirating
• 08719324463058: Device for cutting or coagulating tissue; to be used in combination with an electrosurgical gene
• 08719324463041: Device for use as a delivery system for Hem-o-lok® ML Non-absorbable Polymer Ligation Clips; to
• 08719324463034: Device for cutting tissue; to be used in combination with the symphonX Handle, Handle with ratch
• 08719324463027: Device for grasping and dissecting tissue; to be used in combination with the symphonX Handle, H
• 08719324463119: Device for grasping tissue; to be used in combination with the symphonX Handle, Handle with ratc
• 08719324463102: The symphonX™ Handle with on/off ratchet is for use in combination with the symphonX™ Instru
• 08719324463096: The symphonX™ Handle with ratchet is for use in combination with the symphonX™ Instruments o
• 08719324463089: The symphonX™ Handle is for use in combination with the symphonX™ Instruments of the types:
• 08719324463003: The symphonX™ Introducer is intended to establish a path of entry for laparoscopic Instruments
• 08719324463201: The purpose of the symphonX™ Introducer Clamp is to fix / snug fit lock the symphonX™ Introd
• 08719324463195: The purpose of the symphonX™ Introducer Clamp is to fix / snug fit lock the symphonX™ Introd
• 08719324463188: The symphonX™ Introducer Clamp is to fix / snug fit lock the symphonX™ Introducer to the tro