FDA.reportPublic FDA data

Chole-Cath Biliary Drainage Catheter

Primary DI
H862CCL21050HBKS2
Brand
Chole-Cath Biliary Drainage Catheter
Company
URESIL, LLC
Model
CCL2-1050HB-K
Catalog number
CCL2-1050HB-K
Device description
CHOLE-CATH Biliary Drainage Catheter Kit - 10F
Published
2020-10-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FGECatheter, Biliary, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGEStents, Drains And Dilators For The Biliary DuctsGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K923096000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K923096000URESIL BILLIARY CATHETERUresil Corp.1993-07-13FGE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H862CCL21050HBKS2PackageHIBCC10In Commercial Distribution
H862CCL21050HBKS1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Biliary drainage catheterA flexible tube intended to be introduced percutaneously, for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. It is available in various designs, shapes, and sizes, and may include disposable devices dedicated to catheter introduction. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge10French
Length41Centimeter

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
false
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
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

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