Chole-Cath Biliary Drainage Catheter

Basic Information

• Brand Name: Chole-Cath Biliary Drainage Catheter
• Primary DI: 00817640021186
• Version / Model: CCL2-1250HB
• Catalog Number: CCL2-1250HB
• Company Name: URESIL, LLC
• Labeler DUNS: 192559557
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-04-28
• Public Version: 1
• Public Version Date: 2022-05-06
• Public Version Status: New
• Public Device Record Key: ac85f71a-95e8-44ad-ae50-416240596732

Device Description

HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER AND DEPTH MARKS, 12F

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FGE	Catheter, Biliary, Diagnostic	Gastroenterology, Urology	876.5010	2

GMDN Terms

Code	Name	Definition	Implantable	Status
10696	Biliary drain	A flexible tube intended for percutaneous placement in the abdomen to establish a channel for temporary or prolonged drainage of an obstructed biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. It is distally inserted into the common bile duct, hepatic ducts (transhepatic biliary drainage), or gallbladder (cholecystostomy drainage); disposable devices dedicated to drain introduction may be included with the device. It may be used in conjunction with a low negative pressure system and is available in various designs (e.g., silicone Y- or T-tube, catheter-like, with perforations). This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10817640021183	GS1	Dispenser	5	In Commercial Distribution
Primary	00817640021186	GS1
Package	20817640021180	GS1	Shipper	4	In Commercial Distribution
Previous	H862CCL21250HB0	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K923096	000

Device Sizes

Type	Value	Unit	Text
Catheter Gauge	12	French
Length	40	Centimeter