FDA.reportPublic FDA data

GP General Purpose Drainage Catheter

Primary DI
10817640021138
Brand
GP General Purpose Drainage Catheter
Company
URESIL, LLC
Model
KDL2T-1017H
Catalog number
KDL2T-1017H
Device description
HYDROPHILIC COATED SHORT MINI-PIGTAIL LOCKING CATHETER WITH DEPTH MARKS, 10F
Published
2022-04-27
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
GBOCatheter, Nephrostomy, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBOCatheter, Nephrostomy, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10817640021138PackageGS15In Commercial Distribution
20817640021135PackageGS16In Commercial Distribution
H862KDL2T1017H0PreviousHIBCC0
00817640021131PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081764002113810817640021138
2081764002113520817640021135
00817640021131008176400211318176400211310817640021131

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge10French
Length12Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-538-7374sales@uresil.com

Regulatory Flags#

DUNS number
192559557
Device count
1
DM exempt
false
Premarket exempt
true
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
H862TC600L0Gravity Drainage BagTC600LTC600L2017-09-11
H862TFDR0Tru-Fix Catheter Fixation KitTFD-RTFD-R2016-08-31
H862TFK060Tru-Fix Catheter Fixation KitTFK-06TFK-062016-08-31
H862TFK080Tru-Fix Catheter Fixation KitTFK-08TFK-082016-08-31
H862TFK100Tru-Fix Catheter Fixation KitTFK-10TFK-102016-08-31
H862TFK120Tru-Fix Catheter Fixation KitTFK-12TFK-122016-08-31
H862TFK140Tru-Fix Catheter Fixation KitTFK-14TFK-142016-08-31
H862TFK160Tru-Fix Catheter Fixation KitTFK-16TFK-162016-08-31
00817640020639Tru-Fix Catheter Fixation KitTFD-RTFD-R2022-05-12
00817640020646Tru-Fix Catheter Fixation KitTFK-06TFK-062022-05-12
00817640020653Tru-Fix Catheter Fixation KitTFK-08TFK-082022-05-12
00817640020660Tru-Fix Catheter Fixation KitTFK-10TFK-102022-05-12
00817640020677Tru-Fix Catheter Fixation KitTFK-12TFK-122022-05-12
00817640020684Tru-Fix Catheter Fixation KitTFK-14TFK-142022-05-12
00817640020691Tru-Fix Catheter Fixation KitTFK-16TFK-162022-05-12
H862DFALL0Aspiration and Flush AssemblyDFA-LLDFA-LL2016-08-29
H862TV11100Thora-Vent Thoracic VentTV11-10TV11-102016-09-07
H862TV11130Thora-Vent Thoracic VentTV11-13TV11-132016-09-07
H862TV13100Thora-Vent Thoracic VentTV13-10TV13-102016-09-07
H862TV13130Thora-Vent Thoracic VentTV13-13TV13-132016-09-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15051684011587Total AbscessionAngiodynamics, Inc.GBO2024-10-30
15051684011594Total AbscessionAngiodynamics, Inc.GBO2024-10-30
15051684011600Total AbscessionAngiodynamics, Inc.GBO2024-10-30
15051684011617Total AbscessionAngiodynamics, Inc.GBO2024-10-30
15051684011624Total AbscessionAngiodynamics, Inc.GBO2024-10-30
15051684011631Total AbscessionAngiodynamics, Inc.GBO2024-10-30
15051684011648Total AbscessionAngiodynamics, Inc.GBO2024-10-30
15051684011655Total AbscessionAngiodynamics, Inc.GBO2024-10-30
15051684011662Total AbscessionAngiodynamics, Inc.GBO2024-10-30
00812261011806allDrainALLWIN MEDICAL DEVICES, INC.GBO2024-01-09
00812261012308allDrainALLWIN MEDICAL DEVICES, INC.GBO2024-01-09
00812261012315allDrainALLWIN MEDICAL DEVICES, INC.GBO2024-01-09
00812261019222allDrainALLWIN MEDICAL DEVICES, INC.GBO2024-01-09
00812261012292allDrainALLWIN MEDICAL DEVICES, INC.GBO2024-01-08
00812261012285allDrainALLWIN MEDICAL DEVICES, INC.GBO2023-07-28
00817640020103Aspiration and Flush AssemblyURESIL, LLCGBO2022-05-19
00817640020110Aspiration and Flush AssemblyURESIL, LLCGBO2022-05-19
00817640020202Aspiration and Flush AssemblyURESIL, LLCGBO2022-05-19
00817640020097GP General Purpose Drainage CatheterURESIL, LLCGBO2022-04-29
00817640020219GP General Purpose Drainage CatheterURESIL, LLCGBO2022-04-29
00817640020035GP General Purpose Drainage CatheterURESIL, LLCGBO2022-04-28
00817640020042GP General Purpose Drainage CatheterURESIL, LLCGBO2022-04-28
00817640020066GP General Purpose Drainage CatheterURESIL, LLCGBO2022-04-28
00817640020073GP General Purpose Drainage CatheterURESIL, LLCGBO2022-04-28
00817640020080GP General Purpose Drainage CatheterURESIL, LLCGBO2022-04-28
00817640020059GP General Purpose Drainage CatheterURESIL, LLCGBO2022-04-26
H862MPL2T1230H0GP General Purpose Drainage CatheterURESIL, LLCGBO2021-06-10
H862MPLT21430H0GP General Purpose Drainage CatheterURESIL, LLCGBO2021-06-10
H862GPJT0620H0GP General Purpose Drainage CatheterURESIL, LLCGBO2021-06-09
H862GPJT0825H0GP General Purpose Drainage CatheterURESIL, LLCGBO2021-06-09