Chole-Cath Biliary Drainage Catheter CCL2T-0850HB

GUDID 10817640021169

HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER AND DEPTH MARKS, 8F

URESIL, LLC

Biliary drain Biliary drain Biliary drain Biliary drain Biliary drain Biliary drain Biliary drain Biliary drain Biliary drain Biliary drain Biliary drain Biliary drain Biliary drain Biliary drain Biliary drain
Primary Device ID10817640021169
NIH Device Record Key06732909-78f2-4c1d-94ec-3be529ecb2f4
Commercial Distribution StatusIn Commercial Distribution
Brand NameChole-Cath Biliary Drainage Catheter
Version Model NumberCCL2T-0850HB
Catalog NumberCCL2T-0850HB
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 Gauge8 French
Length41 Centimeter
Catheter Gauge8 French
Length41 Centimeter
Catheter Gauge8 French
Length41 Centimeter
Catheter Gauge8 French
Length41 Centimeter
Catheter Gauge8 French
Length41 Centimeter
Catheter Gauge8 French
Length41 Centimeter
Catheter Gauge8 French
Length41 Centimeter
Catheter Gauge8 French
Length41 Centimeter
Catheter Gauge8 French
Length41 Centimeter
Catheter Gauge8 French
Length41 Centimeter
Catheter Gauge8 French
Length41 Centimeter
Catheter Gauge8 French
Length41 Centimeter
Catheter Gauge8 French
Length41 Centimeter
Catheter Gauge8 French
Length41 Centimeter
Catheter Gauge8 French
Length41 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100817640021162 [Primary]
GS110817640021169 [Package]
Contains: 00817640021162
Package: Dispenser [5 Units]
In Commercial Distribution
GS120817640021166 [Package]
Package: Shipper [4 Units]
In Commercial Distribution
HIBCCH862CCL2T0850HB0 [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 Date2022-05-03
Device Publish Date2022-04-25

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H862CCL20850HBKSA2Biliary "HB" Catheter + Fixation Kit - Locking - 8F 50
H862CCL20850HBK2HYDROPHILIC COATED BILIARY LOCKING CATHETER KIT WITH RADIOPAQUE MARKER AND DEPTH MARKS, 8F
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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
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