FDA.reportPublic FDA data

symphonX™

Primary DI
08719324463072
Brand
symphonX™
Company
Fortimedix Surgical B.V.
Model
Hub Cap & Sealing Unit
Catalog number
314-201
Device description
Device for use in combination with the symphonX Introducer during minimally invasive abdominal laparoscopic surgical procedures
Published
2017-02-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OTJLaparoscopic Single Port Access Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OTJLaparoscopic Single Port Access DeviceGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08719324463072PackageGS112In Commercial Distribution
08719324463171PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08719324463072087193244630728719324463072
08719324463171087193244631718719324463171

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope channel support kitA collection of sterile devices intended to be fitted to multiple endoscope working channels/ports to enable an endoscope operator control the function of the working channels/ports and prevent retrograde flow of fluids, gases, and other materials. It typically includes an endoscopic suction valve, an endoscopic air/water valve, and an endoscopic biopsy valve. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature5 Degrees Celsius45 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+31454047470saleseurope@fortimedix.com

Regulatory Flags#

DUNS number
492888563
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08719324463140symphonX™Clip Applier314-0042017-02-15
08719324463348symphonX™Clip Applier short314-0102017-08-25
08719324463126symphonX™Maryland314-0022017-02-15
08719324463133symphonX™Scissors314-0032017-02-15
08719324463157symphonX™Hook-knife314-0052017-02-15
08719324463164symphonX™Suction/Irrigation314-0062017-02-15
08719324463171symphonX™Hub Cap & Sealing Unit314-2012017-02-15
08719324463188symphonX™Introducer Clamp Type A314-1022019-05-22
08719324463195symphonX™Introducer Clamp Type B314-1032019-05-22
08719324463201symphonX™Introducer Clamp Type C314-1042019-05-22
08719324463003symphonX™Introducer314-1012017-02-15
08719324463089symphonX™Handle314-3012017-02-15
08719324463096symphonX™Handle with ratchet314-3022018-11-28
08719324463102symphonX™Handle with on/off ratchet314-3032018-11-28
08719324463119symphonX™Grasper314-0012017-02-15
08719324463317symphonX™Grasper short314-0072017-08-25
08719324463324symphonX™Maryland short314-0082017-08-25
08719324463331symphonX™Scissors short314-0092017-08-25
08719324463355symphonX™Hook-knife short314-0112017-08-25
08719324463027symphonX™Maryland314-0022017-02-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04055207007808NARichard Wolf GmbHOTJ2024-08-19
04055207069912NARichard Wolf GmbHOTJ2024-08-19
08719324463188symphonX™Fortimedix Surgical B.V.OTJ2019-05-22
08719324463195symphonX™Fortimedix Surgical B.V.OTJ2019-05-22
08719324463201symphonX™Fortimedix Surgical B.V.OTJ2019-05-22
04055207021088NARichard Wolf GmbHOTJ2018-09-24
08719324463171symphonX™Fortimedix Surgical B.V.OTJ2017-02-15
08719324463003symphonX™Fortimedix Surgical B.V.OTJ2017-02-15
04055207011331NARichard Wolf GmbHOTJ2016-10-07
04055207011348NARichard Wolf GmbHOTJ2016-10-07
04055207011324NARichard Wolf GmbHOTJ2016-09-30
04055207021071KEYPORTRichard Wolf GmbHOTJ2016-09-26
04055207011355KEYPORTRichard Wolf GmbHOTJ2016-09-23
04055207011362KEYPORTRichard Wolf GmbHOTJ2016-09-23
04055207011379KEYPORTRichard Wolf GmbHOTJ2016-09-23
04055207011386KEYPORTRichard Wolf GmbHOTJ2016-09-23
04055207021057NARichard Wolf GmbHOTJ2016-09-23
04055207021064NARichard Wolf GmbHOTJ2016-09-23
05391530440073TriPort+ADVANCED SURGICAL CONCEPTS LIMITEDOTJ2016-09-13
05391530440110QuadPort+ADVANCED SURGICAL CONCEPTS LIMITEDOTJ2016-09-13
05391530440066TriPort+ADVANCED SURGICAL CONCEPTS LIMITEDOTJ2016-09-13
05391530440097TriPort15ADVANCED SURGICAL CONCEPTS LIMITEDOTJ2016-09-13
05391530440103QuadPort+ADVANCED SURGICAL CONCEPTS LIMITEDOTJ2016-09-13