FDA.reportPublic FDA data

symphonX™

Primary DI
08719324463140
Brand
symphonX™
Company
Fortimedix Surgical B.V.
Model
Clip Applier
Catalog number
314-004
Device description
Device for use as a delivery system for Hem-o-lok® ML Non-absorbable Polymer Ligation Clips; to be used in combination with the symphonX Handle, Handle with ratchet, Handle with on/off ratchet.
Published
2017-02-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08719324463041PackageGS16Not in Commercial Distribution
08719324463140PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08719324463041087193244630418719324463041
08719324463140087193244631408719324463140

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic surgical ligation clip applier, reusableA hand-held manual surgical instrument intended to be used during an endoscopic (e.g., laparoscopic) surgical procedure to apply small atraumatic clips (not included) for the ligation of blood vessels, or similar tubular anatomy, mainly to prevent and/or stop bleeding (i.e., haemostasis). It is neither designed to apply aneurysm clips nor gastrointestinal clips. It typically includes distal jaws, a slender shaft, and a proximal handle (e.g., trigger-like). The ligation clips are not included. This is a reusable 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

Contacts#

Phone, Email table
PhoneEmail
+18582440033salesusa@fortimedix.com
+31454047470saleseurope@fortimedix.com

Regulatory Flags#

DUNS number
492888563
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
08719324463034symphonX™Scissors314-0032017-02-15

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