Chole-Cath Biliary Drainage Catheter CCL2-1050HX

GUDID H862CCL21050HX2

HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER AND EXTRA HOLES, 10F

URESIL, LLC

Biliary drainage catheter

• Primary Device ID: H862CCL21050HX2
• NIH Device Record Key: d82dba69-e8fe-4420-8c45-331ddb4249e4
• Commercial Distribution Discontinuation: 2020-02-12
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Chole-Cath Biliary Drainage Catheter
• Version Model Number: CCL2-1050HX
• Catalog Number: CCL2-1050HX
• 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

• Length: 41 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	H862CCL21050HX0 [Primary]
HIBCC	H862CCL21050HX1 [Package]; Contains: H862CCL21050HX0; Package: Dispenser [5 Units]; Discontinued: 2020-02-12; Not in Commercial Distribution
HIBCC	H862CCL21050HX2 [Package]; Contains: H862CCL21050HX1; 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: 2016-09-02

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