FDA.reportPublic FDA data

Symphony Centesis Drainage Kit

Primary DI
00817640021520
Brand
Symphony Centesis Drainage Kit
Company
URESIL, LLC
Model
CTK-00
Catalog number
CTK-00
Device description
Symphony Procedure Pack
Published
2020-01-16
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
KGZAccessories, Catheter

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20817640021524PackageGS18Not in Commercial Distribution
00817640021520PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081764002152420817640021524
00817640021520008176400215208176400215200817640021520

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.

Contacts#

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

Regulatory Flags#

DUNS number
192559557
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817640020486Ulti-Flo General Purpose Drainage CatheterLBL2T-1430HBLBL2T-1430HB2022-04-27
00817640020493Ulti-Flo General Purpose Drainage CatheterLBL2T-1630HBLBL2T-1630HB2022-04-27
00817640020998GP General Purpose Drainage CatheterMPL2T-0625HMPL2T-0625H2022-04-27
00817640021339Ulti-Flo General Purpose Drainage CatheterLBL2-1430HBLBL2-1430HB2022-04-28
00817640021346Ulti-Flo General Purpose Drainage CatheterLBL2-1630HBLBL2-1630HB2022-04-28
00817640021643GP General Purpose Drainage CatheterGPL2T-0625HGPL2T-0625H2022-04-27
00817640020165Nephro-Stent Nephroureteral Stent CatheterNSL2T-0822HNSL2T-0822H2022-04-28
00817640020172Nephro-Stent Nephroureteral Stent CatheterNSL2T-0824HNSL2T-0824H2022-04-28
00817640020189Nephro-Stent Nephroureteral Stent CatheterNSL2T-0826HNSL2T-0826H2022-04-28
00817640020196Nephro-Stent Nephroureteral Stent CatheterNSL2T-0828HNSL2T-0828H2022-04-28
00817640020516Nephro-Stent Nephroureteral Stent CatheterNSL2T-1022HNSL2T-1022H2022-04-28
00817640020523Nephro-Stent Nephroureteral Stent CatheterNSL2T-1024HNSL2T-1024H2022-04-28
00817640020530Nephro-Stent Nephroureteral Stent CatheterNSL2T-1026HNSL2T-1026H2022-04-28
00817640020547Nephro-Stent Nephroureteral Stent CatheterNSL2T-1028HNSL2T-1028H2022-04-28
00817640020387Nephro-Stent Nephroureteral Stent CatheterNSL2-0822HNSL2-0822H2022-04-29
00817640020394Nephro-Stent Nephroureteral Stent CatheterNSL2-0824HNSL2-0824H2022-04-29
00817640020400Nephro-Stent Nephroureteral Stent CatheterNSL2-0826HNSL2-0826H2022-04-29
00817640020417Nephro-Stent Nephroureteral Stent CatheterNSL2-0828HNSL2-0828H2022-04-29
00817640020424Nephro-Stent Nephroureteral Stent CatheterNSL2-1022HNSL2-1022H2022-04-29
00817640020431Nephro-Stent Nephroureteral Stent CatheterNSL2-1024HNSL2-1024H2022-04-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06976712970341Hemo Luer LockMicro-Energy Medical Technology Co., LtdKGZ2026-07-13
H787TDST0AngioDynamicsAngiodynamics, Inc.KGZ2026-06-04
00840329837389BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.KGZ2026-05-04
10198459435201MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KGZ2025-07-21
10704411017882AMSure® Single Spike Infiltration TubingAMSINO INTERNATIONAL, INC.KGZ2025-06-23
10192253053609DevonCardinal Health 200, LLCKGZ2025-03-25
10192253042023DevonCardinal Health 200, LLCKGZ2025-03-07
10192253042030DevonCardinal Health 200, LLCKGZ2025-03-07
00840306835087Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2025-01-16
00840306835094Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2025-01-16
00840306835100Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2025-01-16
00840306835131Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2025-01-16
30382904275656BD Intramedic™ Luer-Stub AdapterBECTON, DICKINSON AND COMPANYKGZ2024-08-22
30382904275618BD Intramedic™ Luer-Stub AdapterBECTON, DICKINSON AND COMPANYKGZ2024-08-20
30382904275625BD Intramedic™ Luer-Stub AdapterBECTON, DICKINSON AND COMPANYKGZ2024-08-20
30382904275632BD Intramedic™ Luer-Stub AdapterBECTON, DICKINSON AND COMPANYKGZ2024-08-20
30382904275649BD Intramedic™ Luer-Stub AdapterBECTON, DICKINSON AND COMPANYKGZ2024-08-20
30382904275601BD Intramedic™ Luer-Stub AdapterBECTON, DICKINSON AND COMPANYKGZ2024-08-16
00815634021761FibrijetMicromedics, Inc.KGZ2024-06-18
00628725047638Safety Drain line adapterCanadian Hospital Specialties LimitedKGZ2024-06-17
10193489068245NAMICMEDLINE INDUSTRIES, INC.KGZ2023-12-21
10193489068108MEDLINEMEDLINE INDUSTRIES, INC.KGZ2023-09-18
10193489068115MEDLINEMEDLINE INDUSTRIES, INC.KGZ2023-09-18
10193489068122MEDLINEMEDLINE INDUSTRIES, INC.KGZ2023-09-18
10193489140187MEDLINEMEDLINE INDUSTRIES, INC.KGZ2023-09-18
10193489140194MEDLINEMEDLINE INDUSTRIES, INC.KGZ2023-09-18
M710WW12K0Wire Watch™BIOTEX, INC.KGZ2023-07-31
10850005416002MedDrainARMM INC.KGZ2023-06-08
10850005416019MedDrainARMM INC.KGZ2023-06-08
10850005416033MedDrainARMM INC.KGZ2023-06-08