Protege RX SECX-7-30-135

GUDID 00821684038550

Carotid Stent System

Covidien LP

Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent Bare-metal carotid artery stent
Primary Device ID00821684038550
NIH Device Record Key4090d656-7b64-41d9-b647-5af297ad72d4
Commercial Distribution StatusIn Commercial Distribution
Brand NameProtege RX
Version Model NumberSECX-7-30-135
Catalog NumberSECX-7-30-135
Company DUNS968903703
Company NameCovidien LP
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
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
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
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

Outer Diameter2 Millimeter
Outer Diameter2 Millimeter
Outer Diameter2 Millimeter
Outer Diameter2 Millimeter
Outer Diameter2 Millimeter
Outer Diameter2 Millimeter
Outer Diameter2 Millimeter
Outer Diameter2 Millimeter
Outer Diameter2 Millimeter
Outer Diameter2 Millimeter
Length30 Millimeter
Outer Diameter7 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter2 Millimeter
Length30 Millimeter
Outer Diameter7 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter2 Millimeter
Length30 Millimeter
Outer Diameter7 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter2 Millimeter
Length30 Millimeter
Outer Diameter7 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter2 Millimeter
Length30 Millimeter
Outer Diameter7 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter2 Millimeter
Length30 Millimeter
Outer Diameter7 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter2 Millimeter
Length30 Millimeter
Outer Diameter7 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter2 Millimeter
Length30 Millimeter
Outer Diameter7 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter2 Millimeter
Length30 Millimeter
Outer Diameter7 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter2 Millimeter
Length30 Millimeter
Outer Diameter7 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter2 Millimeter
Length30 Millimeter
Outer Diameter7 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter2 Millimeter
Length30 Millimeter
Outer Diameter7 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter2 Millimeter
Length30 Millimeter
Outer Diameter7 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter2 Millimeter
Length30 Millimeter
Outer Diameter7 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter2 Millimeter
Length30 Millimeter
Outer Diameter7 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter2 Millimeter
Length30 Millimeter
Outer Diameter7 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter2 Millimeter
Length30 Millimeter
Outer Diameter7 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter2 Millimeter
Length30 Millimeter
Outer Diameter7 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter2 Millimeter
Length30 Millimeter
Outer Diameter7 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter2 Millimeter
Length30 Millimeter
Outer Diameter7 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter2 Millimeter
Length30 Millimeter
Outer Diameter7 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter2 Millimeter
Length30 Millimeter
Outer Diameter7 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter2 Millimeter
Length30 Millimeter
Outer Diameter7 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter2 Millimeter
Length30 Millimeter
Outer Diameter7 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter2 Millimeter
Length30 Millimeter
Outer Diameter7 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter2 Millimeter
Length30 Millimeter
Outer Diameter7 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter2 Millimeter
Length30 Millimeter
Outer Diameter7 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter2 Millimeter
Length30 Millimeter
Outer Diameter7 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter2 Millimeter
Length30 Millimeter
Outer Diameter7 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter2 Millimeter
Length30 Millimeter
Outer Diameter7 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter2 Millimeter
Length30 Millimeter
Outer Diameter7 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter2 Millimeter
Length30 Millimeter
Outer Diameter7 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter2 Millimeter
Length30 Millimeter
Outer Diameter7 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter2 Millimeter
Length30 Millimeter
Outer Diameter7 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter2 Millimeter
Length30 Millimeter
Outer Diameter7 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter2 Millimeter
Length30 Millimeter
Outer Diameter7 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter2 Millimeter
Length30 Millimeter
Outer Diameter7 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter2 Millimeter
Length30 Millimeter
Outer Diameter7 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter2 Millimeter
Length30 Millimeter
Outer Diameter7 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Outer Diameter2 Millimeter
Length30 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Length30 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Length30 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Length30 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Length30 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Length30 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Length30 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Length30 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Length30 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Length30 Millimeter
Device Size Text, specify0
Catheter Gauge6 French
Length30 Millimeter
Device Size Text, specify0
Catheter Gauge6 French

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
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry

Device Identifiers

Device Issuing AgencyDevice ID
GS100821684038550 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NIMSTENT, CAROTID

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 Date2014-09-22

On-Brand Devices [Protege RX]

00821684038680Carotid Stent System
00821684038673Carotid Stent System
00821684038666Carotid Stent System
00821684038659Carotid Stent System
00821684038642Carotid Stent System
00821684038635Carotid Stent System
00821684038628Carotid Stent System
00821684038611Carotid Stent System
00821684038604Carotid Stent System
00821684038598Carotid Stent System
00821684038581Carotid Stent System
00821684038574Carotid Stent System
00821684038567Carotid Stent System
00821684038550Carotid Stent System
00821684038543Carotid Stent System
00821684038536Carotid Stent System
00821684038529Carotid Stent System
00821684038512Carotid Stent System
00821684038505Carotid Stent System
00821684038499Carotid Stent System
00821684032220Self-Expanding Biliary Stent System

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.