050907

GUDID 10653405051428

PROFORMA HF 4.5 Cannula, Curved Taper Tip

Conmed Corporation

Cholangiopancreatography catheter, single-use Cholangiopancreatography catheter, single-use ERCP catheter, non-balloon, non-electrical, single-use ERCP catheter, non-balloon, non-electrical, single-use ERCP catheter, non-balloon, non-electrical, single-use ERCP catheter, non-balloon, non-electrical, single-use ERCP catheter, non-balloon, non-electrical, single-use ERCP catheter, non-balloon, non-electrical, single-use ERCP catheter, non-balloon, non-electrical, single-use ERCP catheter, non-balloon, non-electrical, single-use ERCP catheter, non-balloon, non-electrical, single-use ERCP catheter, non-balloon, non-electrical, single-use ERCP catheter, non-balloon, non-electrical, single-use ERCP catheter, non-balloon, non-electrical, single-use ERCP catheter, non-balloon, non-electrical, single-use ERCP catheter, non-balloon, non-electrical, single-use ERCP catheter, non-balloon, non-electrical, single-use ERCP catheter, non-balloon, non-electrical, single-use ERCP catheter, non-balloon, non-electrical, single-use
Primary Device ID10653405051428
NIH Device Record Keyfb154f9f-917b-427a-96ca-1da46fd724df
Commercial Distribution StatusIn Commercial Distribution
Version Model Number050907
Catalog Number050907
Company DUNS071595540
Company NameConmed Corporation
Device Count5
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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM

Device Dimensions

Device Size Text, specify0
Length190 Centimeter
Catheter Gauge4.5 French
Device Size Text, specify0
Outer Diameter0.89 Millimeter
Outer Diameter0.035 Inch
Device Size Text, specify0
Device Size Text, specify0
Length190 Centimeter
Catheter Gauge4.5 French
Device Size Text, specify0
Outer Diameter0.89 Millimeter
Outer Diameter0.035 Inch
Device Size Text, specify0
Device Size Text, specify0
Length190 Centimeter
Catheter Gauge4.5 French
Device Size Text, specify0
Outer Diameter0.89 Millimeter
Outer Diameter0.035 Inch
Device Size Text, specify0
Device Size Text, specify0
Length190 Centimeter
Catheter Gauge4.5 French
Device Size Text, specify0
Outer Diameter0.89 Millimeter
Outer Diameter0.035 Inch
Device Size Text, specify0
Device Size Text, specify0
Length190 Centimeter
Catheter Gauge4.5 French
Device Size Text, specify0
Outer Diameter0.89 Millimeter
Outer Diameter0.035 Inch
Device Size Text, specify0
Device Size Text, specify0
Length190 Centimeter
Catheter Gauge4.5 French
Device Size Text, specify0
Outer Diameter0.89 Millimeter
Outer Diameter0.035 Inch
Device Size Text, specify0
Device Size Text, specify0
Length190 Centimeter
Catheter Gauge4.5 French
Device Size Text, specify0
Outer Diameter0.89 Millimeter
Outer Diameter0.035 Inch
Device Size Text, specify0
Device Size Text, specify0
Length190 Centimeter
Catheter Gauge4.5 French
Device Size Text, specify0
Outer Diameter0.89 Millimeter
Outer Diameter0.035 Inch
Device Size Text, specify0
Device Size Text, specify0
Length190 Centimeter
Catheter Gauge4.5 French
Device Size Text, specify0
Outer Diameter0.89 Millimeter
Outer Diameter0.035 Inch
Device Size Text, specify0
Device Size Text, specify0
Length190 Centimeter
Catheter Gauge4.5 French
Device Size Text, specify0
Outer Diameter0.89 Millimeter
Outer Diameter0.035 Inch
Device Size Text, specify0
Device Size Text, specify0
Length190 Centimeter
Catheter Gauge4.5 French
Device Size Text, specify0
Outer Diameter0.89 Millimeter
Outer Diameter0.035 Inch
Device Size Text, specify0
Device Size Text, specify0
Length190 Centimeter
Catheter Gauge4.5 French
Device Size Text, specify0
Outer Diameter0.89 Millimeter
Outer Diameter0.035 Inch
Device Size Text, specify0
Device Size Text, specify0
Length190 Centimeter
Catheter Gauge4.5 French
Device Size Text, specify0
Outer Diameter0.89 Millimeter
Outer Diameter0.035 Inch
Device Size Text, specify0
Device Size Text, specify0
Length190 Centimeter
Catheter Gauge4.5 French
Device Size Text, specify0
Outer Diameter0.89 Millimeter
Outer Diameter0.035 Inch
Device Size Text, specify0
Device Size Text, specify0
Length190 Centimeter
Catheter Gauge4.5 French
Device Size Text, specify0
Outer Diameter0.89 Millimeter
Outer Diameter0.035 Inch
Device Size Text, specify0
Device Size Text, specify0
Length190 Centimeter
Catheter Gauge4.5 French
Device Size Text, specify0
Outer Diameter0.89 Millimeter
Outer Diameter0.035 Inch
Device Size Text, specify0
Device Size Text, specify0
Length190 Centimeter
Catheter Gauge4.5 French
Device Size Text, specify0
Outer Diameter0.89 Millimeter
Outer Diameter0.035 Inch
Device Size Text, specify0
Device Size Text, specify0
Length190 Centimeter
Catheter Gauge4.5 French
Device Size Text, specify0
Outer Diameter0.89 Millimeter
Outer Diameter0.035 Inch
Device Size Text, specify0
Device Size Text, specify0
Length190 Centimeter
Catheter Gauge4.5 French
Device Size Text, specify0
Outer Diameter0.89 Millimeter
Outer Diameter0.035 Inch
Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween 4 Degrees Celsius and 49 Degrees Celsius
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 49 Degrees Celsius
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 49 Degrees Celsius
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 49 Degrees Celsius
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 49 Degrees Celsius
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 49 Degrees Celsius
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 49 Degrees Celsius
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 49 Degrees Celsius
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 49 Degrees Celsius
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 49 Degrees Celsius
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 49 Degrees Celsius
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 49 Degrees Celsius
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 49 Degrees Celsius
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 49 Degrees Celsius
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 49 Degrees Celsius
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 49 Degrees Celsius
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 49 Degrees Celsius
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 49 Degrees Celsius
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 49 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100653405051421 [Unit of Use]
GS110653405051428 [Package]
Contains: 20653405051425
Package: BOX [5 Units]
In Commercial Distribution
GS120653405051425 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DSACABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)
FGECATHETER, BILIARY, DIAGNOSTIC

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

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