FDA.reportPublic FDA data

symphonX™

Primary DI
08719324463065
Brand
symphonX™
Company
Fortimedix Surgical B.V.
Model
Suction/Irrigation
Catalog number
314-006
Device description
Device for irrigating/ aspirating
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
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
08719324463065PackageGS16In Commercial Distribution
08719324463164PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08719324463065087193244630658719324463065
08719324463164087193244631648719324463164

GMDN Terms#

Term, Definition table
TermDefinition
Suction system catheter, general-purposeA sterile flexible tube used in the removal of fluids from the body via a natural body orifice, surgical incision, or wound. It is typically designed to be attached to a collection canister or bottle where a vacuum is created by a suction system via an intermediate tubing. 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
00724995268312Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
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00724995268350Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
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00724995268381Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268398Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268404Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268411Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268428Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268435Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268442Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268459Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268466Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268473Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
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00724995268497Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268503Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995269517Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995269531Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995269548Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995269555Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995269562Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995269579Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995269593Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
04995047072416CuratOREIZO CORPORATIONGCJ2026-09-25
00190776432348MillenniumAvalign Technologies, Inc.GCJ2026-09-24
00190776432386MillenniumAvalign Technologies, Inc.GCJ2026-09-24
00190776432416MillenniumAvalign Technologies, Inc.GCJ2026-09-24