Chole-Cath Biliary Drainage Catheter

Primary DI: H862CCL20850HB2
Brand: Chole-Cath Biliary Drainage Catheter
Company: URESIL, LLC
Model: CCL2-0850HB
Catalog number: CCL2-0850HB
Device description: HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER AND DEPTH MARKS, 8F
Published: 2016-09-02
Public version status: Update
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#

uresil.com

Product Codes#

Code, Name table
Code	Name
FGE	Catheter, Biliary, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
Code	Device	Specialty	Class
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	2

Premarket Submissions#

Submission, Supplement table
Submission	Supplement
K923096	000

Premarket Details#

Submission, Supplement, Device table
Submission	Supplement	Device	Applicant	Decision date	Product code
K923096	000	URESIL BILLIARY CATHETER	Uresil Corp.	1993-07-13	FGE

Identifiers And Packaging#

Identifier, Type, Agency table
Identifier	Type	Agency	Package quantity	Status
H862CCL20850HB1	Package	HIBCC	5	In Commercial Distribution
H862CCL20850HB2	Package	HIBCC	4	In Commercial Distribution
H862CCL20850HB0	Primary	HIBCC	0

GMDN Terms#

Term, Definition table
Term	Definition
Biliary drainage catheter	A 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
Type	Value	Unit
Catheter Gauge	8	French
Length	41	Centimeter

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number: 192559557
Device count: 1
DM exempt: false
Premarket exempt: false
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 DI	Brand	Model	Catalog	Published
H862TC600L0	Gravity Drainage Bag	TC600L	TC600L	2017-09-11
H862TFDR0	Tru-Fix Catheter Fixation Kit	TFD-R	TFD-R	2016-08-31
H862TFK060	Tru-Fix Catheter Fixation Kit	TFK-06	TFK-06	2016-08-31
H862TFK080	Tru-Fix Catheter Fixation Kit	TFK-08	TFK-08	2016-08-31
H862TFK100	Tru-Fix Catheter Fixation Kit	TFK-10	TFK-10	2016-08-31
H862TFK120	Tru-Fix Catheter Fixation Kit	TFK-12	TFK-12	2016-08-31
H862TFK140	Tru-Fix Catheter Fixation Kit	TFK-14	TFK-14	2016-08-31
H862TFK160	Tru-Fix Catheter Fixation Kit	TFK-16	TFK-16	2016-08-31
00817640020639	Tru-Fix Catheter Fixation Kit	TFD-R	TFD-R	2022-05-12
00817640020646	Tru-Fix Catheter Fixation Kit	TFK-06	TFK-06	2022-05-12
00817640020653	Tru-Fix Catheter Fixation Kit	TFK-08	TFK-08	2022-05-12
00817640020660	Tru-Fix Catheter Fixation Kit	TFK-10	TFK-10	2022-05-12
00817640020677	Tru-Fix Catheter Fixation Kit	TFK-12	TFK-12	2022-05-12
00817640020684	Tru-Fix Catheter Fixation Kit	TFK-14	TFK-14	2022-05-12
00817640020691	Tru-Fix Catheter Fixation Kit	TFK-16	TFK-16	2022-05-12
H862DFALL0	Aspiration and Flush Assembly	DFA-LL	DFA-LL	2016-08-29
H862TV11100	Thora-Vent Thoracic Vent	TV11-10	TV11-10	2016-09-07
H862TV11130	Thora-Vent Thoracic Vent	TV11-13	TV11-13	2016-09-07
H862TV13100	Thora-Vent Thoracic Vent	TV13-10	TV13-10	2016-09-07
H862TV13130	Thora-Vent Thoracic Vent	TV13-13	TV13-13	2016-09-07

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
15711055100400	M-Drain	Mermaid Medical A/S	FGE	2024-10-01
15711055110041	M-Drain	Mermaid Medical A/S	FGE	2024-07-20
15711055110409	M-Drain	Mermaid Medical A/S	FGE	2024-07-20
15711055120040	M-Drain	Mermaid Medical A/S	FGE	2024-01-31
15711055120453	M-Drain	Mermaid Medical A/S	FGE	2024-01-31
15711055000311	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000328	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000359	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000373	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000410	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000434	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000458	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000472	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000496	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000519	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000533	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000557	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000588	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000595	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000625	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000632	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000663	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000670	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000700	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000724	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000748	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000762	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000779	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000809	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000816	M-Drain	Mermaid Medical A/S	FGE	2016-09-24

Chole-Cath Biliary Drainage Catheter

Related Records#

Contact Domains#

Product Codes#

Product Code Classifications#

Premarket Submissions#

Premarket Details#

Identifiers And Packaging#

GMDN Terms#

Device Sizes#

Sterilization Methods#

Contacts#

Regulatory Flags#

Other Devices From This Company#

Other Devices Sharing Product Codes#