Chole-Cath Biliary Drainage Catheter CCL2-1050HBX

GUDID 10817640021176

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

URESIL, LLC

Biliary drain
Primary Device ID10817640021176
NIH Device Record Keybbd2a0e4-65e1-4f4f-8c89-2734bf83bd61
Commercial Distribution StatusIn Commercial Distribution
Brand NameChole-Cath Biliary Drainage Catheter
Version Model NumberCCL2-1050HBX
Catalog NumberCCL2-1050HBX
Company DUNS192559557
Company NameURESIL, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-538-7374
Emailsales@uresil.com
Phone1-800-538-7374
Emailsales@uresil.com
Phone1-800-538-7374
Emailsales@uresil.com
Phone1-800-538-7374
Emailsales@uresil.com
Phone1-800-538-7374
Emailsales@uresil.com
Phone1-800-538-7374
Emailsales@uresil.com
Phone1-800-538-7374
Emailsales@uresil.com
Phone1-800-538-7374
Emailsales@uresil.com
Phone1-800-538-7374
Emailsales@uresil.com
Phone1-800-538-7374
Emailsales@uresil.com
Phone1-800-538-7374
Emailsales@uresil.com
Phone1-800-538-7374
Emailsales@uresil.com
Phone1-800-538-7374
Emailsales@uresil.com
Phone1-800-538-7374
Emailsales@uresil.com
Phone1-800-538-7374
Emailsales@uresil.com

Device Dimensions

Catheter Gauge10 French
Length41 Centimeter
Catheter Gauge10 French
Length41 Centimeter
Catheter Gauge10 French
Length41 Centimeter
Catheter Gauge10 French
Length41 Centimeter
Catheter Gauge10 French
Length41 Centimeter
Catheter Gauge10 French
Length41 Centimeter
Catheter Gauge10 French
Length41 Centimeter
Catheter Gauge10 French
Length41 Centimeter
Catheter Gauge10 French
Length41 Centimeter
Catheter Gauge10 French
Length41 Centimeter
Catheter Gauge10 French
Length41 Centimeter
Catheter Gauge10 French
Length41 Centimeter
Catheter Gauge10 French
Length41 Centimeter
Catheter Gauge10 French
Length41 Centimeter
Catheter Gauge10 French
Length41 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100817640021179 [Primary]
GS110817640021176 [Package]
Contains: 00817640021179
Package: Dispenser [5 Units]
In Commercial Distribution
GS120817640021173 [Package]
Package: Shipper [4 Units]
In Commercial Distribution
HIBCCH862CCL21050HBX0 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FGECatheter, Biliary, Diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-04
Device Publish Date2022-04-26

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

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H862CCL21250H2HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER, 12F
H862CCL21050HX2HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER AND EXTRA HOLES, 10F
H862CCL21050H2HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER, 10F
H862CCL20850HX2HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER AND EXTRA HOLES, 8F
H862CCL20850H2HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER, 8F
H862CCL21650HB2HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER AND DEPTH MARKS, 16F
H862CCL21450HB2HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER AND DEPTH MARKS, 14F
H862CCL21250HBX2HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER, DEPTH MARKS, AND EXTRA HOLES
H862CCL21250HB2HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER AND DEPTH MARKS, 12F
H862CCL21050HBX2HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER, DEPTH MARKS, AND EXTRA HOLES
H862CCL21050HBKSA2Biliary "HB" Catheter + Fixation Kit - Locking - 10F 50
H862CCL21050HBK2HYDROPHILIC COATED BILIARY LOCKING CATHETER KIT WITH RADIOPAQUE MARKER AND DEPTH MARKS, 10F
H862CCL21050HB2HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER AND DEPTH MARKS, 10F
H862CCL20850HBX2HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER, DEPTH MARKS, AND EXTRA HOLES
H862CCL20850HBKSA2Biliary "HB" Catheter + Fixation Kit - Locking - 8F 50
H862CCL20850HBK2HYDROPHILIC COATED BILIARY LOCKING CATHETER KIT WITH RADIOPAQUE MARKER AND DEPTH MARKS, 8F
H862CCL20850HB2HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER AND DEPTH MARKS, 8F
H862CCL21050HBKS2CHOLE-CATH Biliary Drainage Catheter Kit - 10F
H862CCL20850HBKS2CHOLE-CATH Biliary Drainage Catheter Kit - 8F
20817640021593CHOLE-CATH Biliary Drainage Catheter Kit - 10F
20817640021586CHOLE-CATH Biliary Drainage Catheter Kit - 8F
20817640020138CHOLE-CATH Biliary Drainage Catheter Kit - 10F
20817640020121CHOLE-CATH Biliary Drainage Catheter Kit - 8F
H862CCL2T1650HB1HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER AND DEPTH MARKS, 16F
H862CCL2T1450HB1HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER AND DEPTH MARKS, 14F
H862CCL2T1250HBX1HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER, DEPTH MARKS, AND EXTRA HOLES
H862CCL2T1250HB1HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER AND DEPTH MARKS, 12F
H862CCL2T1050HBX1HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER, DEPTH MARKS, AND EXTRA HOLES
H862CCL2T1050HB1HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER AND DEPTH MARKS, 10F
H862CCL2T0850HBX1HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER, DEPTH MARKS, AND EXTRA HOLES
H862CCL2T0850HB1HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER AND DEPTH MARKS, 8F
10817640021169HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER AND DEPTH MARKS, 8F
10817640021497HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER, DEPTH MARKS, AND EXTRA HOLES
10817640021480HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER AND DEPTH MARKS, 12F
10817640021473HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER AND DEPTH MARKS, 10F
10817640021381HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER, DEPTH MARKS, AND EXTRA HOLES
10817640021176HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER, DEPTH MARKS, AND EXTRA HOLES
10817640021633HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER AND DEPTH MARKS, 16F
10817640021626HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER AND DEPTH MARKS, 14F
10817640021213HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER AND DEPTH MARKS, 16F
10817640021206HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER AND DEPTH MARKS, 14F
10817640021190HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER, DEPTH MARKS, AND EXTRA HOLES
10817640021183HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER AND DEPTH MARKS, 12F
10817640021152HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER AND DEPTH MARKS, 10F
10817640021145HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER, DEPTH MARKS, AND EXTRA HOLES
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