Chole-Cath Biliary Drainage Catheter CCL2-0850H

GUDID H862CCL20850H2

HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER, 8F

URESIL, LLC

Biliary drainage catheter

• Primary Device ID: H862CCL20850H2
• NIH Device Record Key: 35c51cb1-f3c0-45a1-adb4-0d6aad824587
• Commercial Distribution Discontinuation: 2020-02-12
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Chole-Cath Biliary Drainage Catheter
• Version Model Number: CCL2-0850H
• Catalog Number: CCL2-0850H
• Company DUNS: 192559557
• Company Name: URESIL, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-538-7374
• Email: sales@uresil.com

Device Dimensions

• Catheter Gauge: 8 French

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	H862CCL20850H0 [Primary]
HIBCC	H862CCL20850H1 [Package]; Contains: H862CCL20850H0; Package: Dispenser [5 Units]; Discontinued: 2020-02-12; Not in Commercial Distribution
HIBCC	H862CCL20850H2 [Package]; Contains: H862CCL20850H1; Package: Shipper [4 Units]; Discontinued: 2020-02-12; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K923096

FDA Product Code

• FGE: Catheter, Biliary, Diagnostic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-02-13
• Device Publish Date: 2016-08-25

On-Brand Devices [Chole-Cath Biliary Drainage Catheter]

• H862CCL21450H2: HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER, 14F
• H862CCL21250HX2: HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER AND EXTRA HOLES, 12F
• H862CCL21250H2: HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER, 12F
• H862CCL21050HX2: HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER AND EXTRA HOLES, 10F
• H862CCL21050H2: HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER, 10F
• H862CCL20850HX2: HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER AND EXTRA HOLES, 8F
• H862CCL20850H2: HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER, 8F
• H862CCL21650HB2: HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER AND DEPTH MARKS, 16F
• H862CCL21450HB2: HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER AND DEPTH MARKS, 14F
• H862CCL21250HBX2: HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER, DEPTH MARKS, AND EXTRA HOLES
• H862CCL21250HB2: HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER AND DEPTH MARKS, 12F
• H862CCL21050HBX2: HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER, DEPTH MARKS, AND EXTRA HOLES
• H862CCL21050HBKSA2: Biliary "HB" Catheter + Fixation Kit - Locking - 10F 50
• H862CCL21050HBK2: HYDROPHILIC COATED BILIARY LOCKING CATHETER KIT WITH RADIOPAQUE MARKER AND DEPTH MARKS, 10F
• H862CCL21050HB2: HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER AND DEPTH MARKS, 10F
• H862CCL20850HBX2: HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER, DEPTH MARKS, AND EXTRA HOLES
• H862CCL20850HBKSA2: Biliary "HB" Catheter + Fixation Kit - Locking - 8F 50
• H862CCL20850HBK2: HYDROPHILIC COATED BILIARY LOCKING CATHETER KIT WITH RADIOPAQUE MARKER AND DEPTH MARKS, 8F
• H862CCL20850HB2: HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER AND DEPTH MARKS, 8F
• H862CCL21050HBKS2: CHOLE-CATH Biliary Drainage Catheter Kit - 10F
• H862CCL20850HBKS2: CHOLE-CATH Biliary Drainage Catheter Kit - 8F
• 20817640021593: CHOLE-CATH Biliary Drainage Catheter Kit - 10F
• 20817640021586: CHOLE-CATH Biliary Drainage Catheter Kit - 8F
• 20817640020138: CHOLE-CATH Biliary Drainage Catheter Kit - 10F
• 20817640020121: CHOLE-CATH Biliary Drainage Catheter Kit - 8F
• H862CCL2T1650HB1: HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER AND DEPTH MARKS, 16F
• H862CCL2T1450HB1: HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER AND DEPTH MARKS, 14F
• H862CCL2T1250HBX1: HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER, DEPTH MARKS, AND EXTRA HOLES
• H862CCL2T1250HB1: HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER AND DEPTH MARKS, 12F
• H862CCL2T1050HBX1: HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER, DEPTH MARKS, AND EXTRA HOLES
• H862CCL2T1050HB1: HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER AND DEPTH MARKS, 10F
• H862CCL2T0850HBX1: HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER, DEPTH MARKS, AND EXTRA HOLES
• H862CCL2T0850HB1: HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER AND DEPTH MARKS, 8F
• 10817640021169: HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER AND DEPTH MARKS, 8F
• 10817640021497: HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER, DEPTH MARKS, AND EXTRA HOLES
• 10817640021480: HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER AND DEPTH MARKS, 12F
• 10817640021473: HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER AND DEPTH MARKS, 10F
• 10817640021381: HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER, DEPTH MARKS, AND EXTRA HOLES
• 10817640021176: HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER, DEPTH MARKS, AND EXTRA HOLES
• 10817640021633: HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER AND DEPTH MARKS, 16F
• 10817640021626: HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER AND DEPTH MARKS, 14F
• 10817640021213: HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER AND DEPTH MARKS, 16F
• 10817640021206: HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER AND DEPTH MARKS, 14F
• 10817640021190: HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER, DEPTH MARKS, AND EXTRA HOLES
• 10817640021183: HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER AND DEPTH MARKS, 12F
• 10817640021152: HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER AND DEPTH MARKS, 10F
• 10817640021145: HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER, DEPTH MARKS, AND EXTRA HOLES
• 10817640021121: HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER AND DEPTH MARKS, 8F