FDA.reportPublic FDA data

Symphony Centesis Drainage Kit

Primary DI
00817640020028
Brand
Symphony Centesis Drainage Kit
Company
URESIL, LLC
Model
CTK-6
Catalog number
CTK-6
Device description
Symphony 6F Drainage Kit
Published
2020-01-16
Public version status
New
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
KGZAccessories, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGZAccessories, CatheterGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20817640021517PackageGS18In Commercial Distribution
00817640020028PreviousGS10
00817640021513PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081764002151720817640021517
00817640020028008176400200288176400200280817640020028
00817640021513008176400215138176400215130817640021513

GMDN Terms#

Term, Definition table
TermDefinition
Pleurocentesis/paracentesis kitA collection of sterile surgical devices intended for acute (i.e., non-indwelling) therapeutic or diagnostic aspiration of fluids or air from the pleural and/or peritoneal cavities. It includes a dedicated needle, syringe, and appropriate support devices (e.g., dressings, drapes); it does not include a drainage catheter and does not contain pharmaceuticals. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge6French
Length10Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-538-7374sales@uresil.com

Regulatory Flags#

DUNS number
192559557
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
H862TC600L0Gravity Drainage BagTC600LTC600L2017-09-11
40817640021757Tru-Close Suction Drainage SystemTCS300DTCS300D2025-08-05
40817640021764Tru-Close Suction Drainage SystemTCS500DSTCS500DS2025-08-05
00817640021704Tru-Close Suction Drainage SystemTCS1000TCS10002024-11-11
00817640021711Tru-Close Suction Drainage SystemTCS300DTCS300D2024-11-11
00817640021728Tru-Close Suction Drainage SystemTCS500TCS5002024-11-11
00817640021735Tru-Close Suction Drainage SystemTCS500DTCS500D2024-11-11
00817640021742Tru-Close Suction Drainage SystemTCS500DSTCS500DS2024-11-11
20817640020473Drainage BagPDC-36PDC-362022-06-03
10817640020506Posi-Stick Introducer SetPS2-1SPS2-1S2022-06-03
10817640020629Tru-Close Suction Drainage SystemTCY2TCY22022-06-03
10817640020797Thora-Vent Thoracic VentTVOCPTVOCP2022-06-03
10817640020803Thora-Vent Thoracic VentTVSTTVST2022-06-03
10817640020469Thora-Vent Thoracic VentOTW11-13OTW11-132022-06-02
10817640020100Aspiration and Flush AssemblyAFA-LBAFA-LB2022-05-19
10817640020117Aspiration and Flush AssemblyAFA-LLAFA-LL2022-05-19
10817640020209Aspiration and Flush AssemblyDFA-LLDFA-LL2022-05-19
10817640020636Tru-Fix Catheter Fixation KitTFD-RTFD-R2022-05-12
10817640020643Tru-Fix Catheter Fixation KitTFK-06TFK-062022-05-12
10817640020650Tru-Fix Catheter Fixation KitTFK-08TFK-082022-05-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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40198459435202MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KGZ2025-07-21
40704411017883AMSure® Single Spike Infiltration TubingAMSINO INTERNATIONAL, INC.KGZ2025-06-23
04048223118702FixoLongPajunk GmbH MedizintechnologieKGZ2025-04-04
05708932767811SopranoColoplast A/SKGZ2025-03-26
20192253053606DevonCardinal Health 200, LLCKGZ2025-03-25
20192253042020DevonCardinal Health 200, LLCKGZ2025-03-07
20192253042037DevonCardinal Health 200, LLCKGZ2025-03-07
00840306834936Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2024-12-11
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00840306836039Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2024-10-23
10884521811546RitusCovidien LPKGZ2024-10-21
00840306835162Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2024-10-10
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00840306835216Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2024-10-10
00840306835223Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2024-10-10
00840306835230Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2024-10-10
00840306835247Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2024-10-10
05708932767545Insertion ToolCOLOPLAST CORP.KGZ2024-09-27
50382904275650BD Intramedic™ Luer-Stub AdapterBECTON, DICKINSON AND COMPANYKGZ2024-08-22
50382904275612BD Intramedic™ Luer-Stub AdapterBECTON, DICKINSON AND COMPANYKGZ2024-08-20
50382904275629BD Intramedic™ Luer-Stub AdapterBECTON, DICKINSON AND COMPANYKGZ2024-08-20
50382904275636BD Intramedic™ Luer-Stub AdapterBECTON, DICKINSON AND COMPANYKGZ2024-08-20