FDA.reportPublic FDA data

GP General Purpose Drainage Catheter

Primary DI
10817640021114
Brand
GP General Purpose Drainage Catheter
Company
URESIL, LLC
Model
KDL2T-0817H
Catalog number
KDL2T-0817H
Device description
HYDROPHILIC COATED SHORT MINI-PIGTAIL LOCKING CATHETER WITH DEPTH MARKS, 8F
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
10817640021114PackageGS15In Commercial Distribution
20817640021111PackageGS16In Commercial Distribution
H862KDL2T0817H0PreviousHIBCC0
00817640021117PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081764002111410817640021114
2081764002111120817640021111
00817640021117008176400211178176400211170817640021117

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 Gauge8French
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
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

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