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

• 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