Home GUDID 00817640021384 Chole-Cath Biliary Drainage Catheter
Primary DI 00817640021384
Brand Chole-Cath Biliary Drainage Catheter
Company URESIL, LLC
Model CCL2T-0850HBX
Catalog number CCL2T-0850HBX
Device description HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER, DEPTH MARKS, AND EXTRA HOLES, 8F
Published 2022-04-26
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true 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
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10817640021381 Package GS1 5 In Commercial Distribution 20817640021388 Package GS1 4 In Commercial Distribution H862CCL2T0850HBX0 Previous HIBCC 0 00817640021384 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10817640021381 10817640021381 20817640021388 20817640021388 00817640021384 00817640021384 817640021384 0817640021384
GMDN Terms# Term, Definition table Term Definition 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.
Device Sizes# Type, Value, Unit table Type Value Unit Catheter Gauge 8 French Length 41 Centimeter
Regulatory Flags# DUNS number 192559557 Device count 1 Lot or batch true Expiration date on label true No natural rubber latex true 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
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