symphonX™ 314-102

GUDID 08719324463188

The symphonX™ Introducer Clamp is to fix / snug fit lock the symphonX™ Introducer to the trocar in axial direction during surgery.

Fortimedix Surgical B.V.

Laparoscopic multi-instrument access port, reusable
Primary Device ID08719324463188
NIH Device Record Key62d073aa-4e2b-4031-9c53-dc67a3cdf8c2
Commercial Distribution StatusIn Commercial Distribution
Brand NamesymphonX™
Version Model NumberIntroducer Clamp Type A
Catalog Number314-102
Company DUNS492888563
Company NameFortimedix Surgical B.V.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+31454047470
Emailsaleseurope@fortimedix.com
Phone+31454047470
Emailsaleseurope@fortimedix.com
Phone+31454047470
Emailsaleseurope@fortimedix.com
Phone+31454047470
Emailsaleseurope@fortimedix.com
Phone+31454047470
Emailsaleseurope@fortimedix.com
Phone+31454047470
Emailsaleseurope@fortimedix.com
Phone+31454047470
Emailsaleseurope@fortimedix.com
Phone+31454047470
Emailsaleseurope@fortimedix.com
Phone+31454047470
Emailsaleseurope@fortimedix.com
Phone+31454047470
Emailsaleseurope@fortimedix.com
Phone+31454047470
Emailsaleseurope@fortimedix.com
Phone+31454047470
Emailsaleseurope@fortimedix.com
Phone+31454047470
Emailsaleseurope@fortimedix.com
Phone+31454047470
Emailsaleseurope@fortimedix.com

Operating and Storage Conditions

Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS108719324463188 [Primary]

FDA Product Code

OTJLaparoscopic Single Port Access Device

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08719324463188]

Moist Heat or Steam Sterilization


[08719324463188]

Moist Heat or Steam Sterilization


[08719324463188]

Moist Heat or Steam Sterilization


[08719324463188]

Moist Heat or Steam Sterilization


[08719324463188]

Moist Heat or Steam Sterilization


[08719324463188]

Moist Heat or Steam Sterilization


[08719324463188]

Moist Heat or Steam Sterilization


[08719324463188]

Moist Heat or Steam Sterilization


[08719324463188]

Moist Heat or Steam Sterilization


[08719324463188]

Moist Heat or Steam Sterilization


[08719324463188]

Moist Heat or Steam Sterilization


[08719324463188]

Moist Heat or Steam Sterilization


[08719324463188]

Moist Heat or Steam Sterilization


[08719324463188]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-11-15
Device Publish Date2019-05-22

On-Brand Devices [symphonX™]

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

Trademark Results [symphonX]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SYMPHONX
SYMPHONX
87172320 5338097 Live/Registered
Fortimedix Surgical B.V.
2016-09-15
SYMPHONX
SYMPHONX
79302302 not registered Live/Pending
FUJIFILM Diosynth Biotechnologies UK Limited
2020-07-09

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