Protege RX SEBX-8-40-135

GUDID 00821684032220

Self-Expanding Biliary Stent System

Covidien LP

Bare-metal biliary stent
Primary Device ID00821684032220
NIH Device Record Key87771c00-624b-44ed-9d86-75b8defc5a5b
Commercial Distribution StatusIn Commercial Distribution
Brand NameProtege RX
Version Model NumberSEBX-8-40-135
Catalog NumberSEBX-8-40-135
Company DUNS968903703
Company NameCovidien LP
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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter8 Millimeter
Length135 Centimeter
Catheter Gauge6 French
Device Size Text, specify0
Outer Diameter8 Millimeter
Length135 Centimeter
Catheter Gauge6 French
Device Size Text, specify0
Outer Diameter8 Millimeter
Length135 Centimeter
Catheter Gauge6 French
Device Size Text, specify0
Outer Diameter8 Millimeter
Length135 Centimeter
Catheter Gauge6 French
Device Size Text, specify0
Outer Diameter8 Millimeter
Length135 Centimeter
Catheter Gauge6 French
Device Size Text, specify0
Outer Diameter8 Millimeter
Length135 Centimeter
Catheter Gauge6 French
Device Size Text, specify0
Outer Diameter8 Millimeter
Length135 Centimeter
Catheter Gauge6 French
Device Size Text, specify0
Outer Diameter8 Millimeter
Length135 Centimeter
Catheter Gauge6 French
Device Size Text, specify0
Outer Diameter8 Millimeter
Length135 Centimeter
Catheter Gauge6 French
Device Size Text, specify0
Outer Diameter8 Millimeter
Length135 Centimeter
Catheter Gauge6 French
Device Size Text, specify0
Outer Diameter8 Millimeter
Length135 Centimeter
Catheter Gauge6 French
Device Size Text, specify0
Outer Diameter8 Millimeter
Length135 Centimeter
Catheter Gauge6 French
Device Size Text, specify0
Outer Diameter8 Millimeter
Length135 Centimeter
Catheter Gauge6 French
Device Size Text, specify0
Outer Diameter8 Millimeter
Length135 Centimeter
Catheter Gauge6 French
Device Size Text, specify0
Outer Diameter8 Millimeter
Length135 Centimeter
Catheter Gauge6 French
Device Size Text, specify0
Outer Diameter8 Millimeter
Length135 Centimeter
Catheter Gauge6 French
Device Size Text, specify0

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT

Device Identifiers

Device Issuing AgencyDevice ID
GS100821684032220 [Primary]

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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-23

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00821684032220Self-Expanding Biliary Stent System
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