EverFlex PRB35-08-120-120

GUDID 00821684034392

Self-Expanding Peripheral Stent System

Covidien LP

Multiple peripheral artery stent, bare-metal
Primary Device ID00821684034392
NIH Device Record Key1f514575-73f1-456c-9390-0df371e08385
Commercial Distribution StatusIn Commercial Distribution
Brand NameEverFlex
Version Model NumberPRB35-08-120-120
Catalog NumberPRB35-08-120-120
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
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

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
Device Size Text, specify0
Device Size Text, specify0
Length120 Millimeter
Outer Diameter8 Millimeter
Catheter Gauge6 French
Outer Diameter2 Millimeter
Device Size Text, specify0
Length120 Millimeter
Outer Diameter8 Millimeter
Catheter Gauge6 French
Outer Diameter2 Millimeter
Device Size Text, specify0
Length120 Millimeter
Outer Diameter8 Millimeter
Catheter Gauge6 French
Outer Diameter2 Millimeter
Device Size Text, specify0
Length120 Millimeter
Outer Diameter8 Millimeter
Catheter Gauge6 French
Outer Diameter2 Millimeter
Device Size Text, specify0
Length120 Millimeter
Outer Diameter8 Millimeter
Catheter Gauge6 French
Outer Diameter2 Millimeter
Device Size Text, specify0
Length120 Millimeter
Outer Diameter8 Millimeter
Catheter Gauge6 French
Outer Diameter2 Millimeter
Device Size Text, specify0
Length120 Millimeter
Outer Diameter8 Millimeter
Catheter Gauge6 French
Outer Diameter2 Millimeter
Device Size Text, specify0
Length120 Millimeter
Outer Diameter8 Millimeter
Catheter Gauge6 French
Outer Diameter2 Millimeter
Device Size Text, specify0
Length120 Millimeter
Outer Diameter8 Millimeter
Catheter Gauge6 French
Outer Diameter2 Millimeter
Device Size Text, specify0
Length120 Millimeter
Outer Diameter8 Millimeter
Catheter Gauge6 French
Outer Diameter2 Millimeter
Device Size Text, specify0
Length120 Millimeter
Outer Diameter8 Millimeter
Catheter Gauge6 French
Outer Diameter2 Millimeter
Device Size Text, specify0
Length120 Millimeter
Outer Diameter8 Millimeter
Catheter Gauge6 French
Outer Diameter2 Millimeter
Device Size Text, specify0
Length120 Millimeter
Outer Diameter8 Millimeter
Catheter Gauge6 French
Outer Diameter2 Millimeter
Device Size Text, specify0
Length120 Millimeter
Outer Diameter8 Millimeter
Catheter Gauge6 French
Outer Diameter2 Millimeter
Device Size Text, specify0
Length120 Millimeter
Outer Diameter8 Millimeter
Catheter Gauge6 French
Outer Diameter2 Millimeter
Device Size Text, specify0
Length120 Millimeter
Outer Diameter8 Millimeter
Catheter Gauge6 French
Outer Diameter2 Millimeter
Device Size Text, specify0
Length120 Millimeter
Outer Diameter8 Millimeter
Catheter Gauge6 French
Outer Diameter2 Millimeter
Device Size Text, specify0
Length120 Millimeter
Outer Diameter8 Millimeter
Catheter Gauge6 French
Outer Diameter2 Millimeter
Device Size Text, specify0
Length120 Millimeter
Outer Diameter8 Millimeter
Catheter Gauge6 French
Outer Diameter2 Millimeter
Device Size Text, specify0
Length120 Millimeter
Outer Diameter8 Millimeter
Catheter Gauge6 French
Outer Diameter2 Millimeter
Device Size Text, specify0
Length120 Millimeter
Outer Diameter8 Millimeter
Catheter Gauge6 French
Outer Diameter2 Millimeter
Device Size Text, specify0
Length120 Millimeter
Outer Diameter8 Millimeter
Catheter Gauge6 French
Outer Diameter2 Millimeter
Device Size Text, specify0
Length120 Millimeter
Outer Diameter8 Millimeter
Catheter Gauge6 French
Outer Diameter2 Millimeter
Device Size Text, specify0
Length120 Millimeter
Outer Diameter8 Millimeter
Catheter Gauge6 French
Outer Diameter2 Millimeter
Device Size Text, specify0
Length120 Millimeter
Outer Diameter8 Millimeter
Catheter Gauge6 French
Outer Diameter2 Millimeter
Device Size Text, specify0
Length120 Millimeter
Outer Diameter8 Millimeter
Catheter Gauge6 French
Outer Diameter2 Millimeter
Device Size Text, specify0
Length120 Millimeter
Outer Diameter8 Millimeter
Catheter Gauge6 French
Outer Diameter2 Millimeter
Device Size Text, specify0
Length120 Millimeter
Outer Diameter8 Millimeter
Catheter Gauge6 French
Outer Diameter2 Millimeter
Device Size Text, specify0
Length120 Millimeter
Outer Diameter8 Millimeter
Catheter Gauge6 French
Outer Diameter2 Millimeter
Device Size Text, specify0
Length120 Millimeter
Outer Diameter8 Millimeter
Catheter Gauge6 French
Outer Diameter2 Millimeter
Device Size Text, specify0
Length120 Millimeter
Outer Diameter8 Millimeter
Catheter Gauge6 French
Outer Diameter2 Millimeter
Device Size Text, specify0
Length120 Millimeter
Outer Diameter8 Millimeter
Catheter Gauge6 French
Outer Diameter2 Millimeter
Device Size Text, specify0
Length120 Millimeter
Outer Diameter8 Millimeter
Catheter Gauge6 French
Outer Diameter2 Millimeter
Device Size Text, specify0
Length120 Millimeter
Outer Diameter8 Millimeter
Catheter Gauge6 French
Outer Diameter2 Millimeter
Device Size Text, specify0
Length120 Millimeter
Outer Diameter8 Millimeter
Catheter Gauge6 French
Outer Diameter2 Millimeter
Device Size Text, specify0
Length120 Millimeter
Outer Diameter8 Millimeter
Catheter Gauge6 French
Outer Diameter2 Millimeter
Device Size Text, specify0
Length120 Millimeter
Outer Diameter8 Millimeter
Catheter Gauge6 French
Outer Diameter2 Millimeter
Device Size Text, specify0
Length120 Millimeter
Outer Diameter8 Millimeter
Catheter Gauge6 French
Outer Diameter2 Millimeter
Device Size Text, specify0
Length120 Millimeter
Outer Diameter8 Millimeter
Catheter Gauge6 French
Outer Diameter2 Millimeter
Device Size Text, specify0
Length120 Millimeter
Outer Diameter8 Millimeter
Catheter Gauge6 French
Outer Diameter2 Millimeter
Device Size Text, specify0
Length120 Millimeter
Outer Diameter8 Millimeter
Catheter Gauge6 French
Outer Diameter2 Millimeter
Device Size Text, specify0
Length120 Millimeter
Outer Diameter8 Millimeter
Catheter Gauge6 French
Outer Diameter2 Millimeter
Device Size Text, specify0
Length120 Millimeter
Outer Diameter8 Millimeter
Catheter Gauge6 French
Outer Diameter2 Millimeter
Device Size Text, specify0
Length120 Millimeter
Outer Diameter8 Millimeter
Catheter Gauge6 French
Outer Diameter2 Millimeter
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
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100821684034392 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NIPSTENT, SUPERFICIAL FEMORAL ARTERY

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 [EverFlex]

00821684069615STENT PRB35-08-200-120 PROTEGE EF V10
00821684069608STENT PRB35-08-150-120 PROTEGE EF V10
00821684069592STENT PRB35-08-150-080 PROTEGE EF V10
00821684069585STENT PRB35-08-120-120 PROTEGE EF V10
00821684069578STENT PRB35-08-120-080 PROTEGE EF V10
00821684069561STENT PRB35-08-100-120 PROTEGE EF V10
00821684069554STENT PRB35-08-100-080 PROTEGE EF V10
00821684069547STENT PRB35-08-080-120 PROTEGE EF V10
00821684069530STENT PRB35-08-080-080 PROTEGE EF V10
00821684069523STENT PRB35-08-060-120 PROTEGE EF V10
00821684069516STENT PRB35-08-060-080 PROTEGE EF V10
00821684069509STENT PRB35-08-040-120 PROTEGE EF V10
00821684069493STENT PRB35-08-040-080 PROTEGE EF V10
00821684069486STENT PRB35-08-030-120 PROTEGE EF V10
00821684069479STENT PRB35-08-030-080 PROTEGE EF V10
00821684069462STENT PRB35-08-020-120 PROTEGE EF V10
00821684069455STENT PRB35-08-020-080 PROTEGE EF V10
00821684069448STENT PRB35-07-200-120 PROTEGE EF V10
00821684069431STENT PRB35-07-150-120 PROTEGE EF V10
00821684069424STENT PRB35-07-150-080 PROTEGE EF V10
00821684069417STENT PRB35-07-120-120 PROTEGE EF V10
00821684069400STENT PRB35-07-120-080 PROTEGE EF V10
00821684069394STENT PRB35-07-100-120 PROTEGE EF V10
00821684069387STENT PRB35-07-100-080 PROTEGE EF V10
00821684069370STENT PRB35-07-080-120 PROTEGE EF V10
00821684069363STENT PRB35-07-080-080 PROTEGE EF V10
00821684069356STENT PRB35-07-060-120 PROTEGE EF V10
00821684069349STENT PRB35-07-060-080 PROTEGE EF V10
00821684069332STENT PRB35-07-040-120 PROTEGE EF V10
00821684069325STENT PRB35-07-040-080 PROTEGE EF V10
00821684069318STENT PRB35-07-030-120 PROTEGE EF V10
00821684069301STENT PRB35-07-030-080 PROTEGE EF V10
00821684069295STENT PRB35-07-020-120 PROTEGE EF V10
00821684069288STENT PRB35-07-020-080 PROTEGE EF V10
00821684069271STENT PRB35-06-200-120 PROTEGE EF V10
00821684069264STENT PRB35-06-150-120 PROTEGE EF V10
00821684069257STENT PRB35-06-150-080 PROTEGE EF V10
00821684069240STENT PRB35-06-120-120 PROTEGE EF V10
00821684069233STENT PRB35-06-120-080 PROTEGE EF V10
00821684069226STENT PRB35-06-100-120 PROTEGE EF V10
00821684069219STENT PRB35-06-100-080 PROTEGE EF V10
00821684069202STENT PRB35-06-080-120 PROTEGE EF V10
00821684069196STENT PRB35-06-080-080 PROTEGE EF V10
00821684069189STENT PRB35-06-060-120 PROTEGE EF V10
00821684069172STENT PRB35-06-060-080 PROTEGE EF V10
00821684069165STENT PRB35-06-040-120 PROTEGE EF V10
00821684069158STENT PRB35-06-040-080 PROTEGE EF V10
00821684069141STENT PRB35-06-030-120 PROTEGE EF V10
00821684069134STENT PRB35-06-030-080 PROTEGE EF V10
00821684069127STENT PRB35-06-020-120 PROTEGE EF V10

Trademark Results [EverFlex]

Mark Image

Registration | Serial
Company
Trademark
Application Date
EVERFLEX
EVERFLEX
97549909 not registered Live/Pending
CornellCookson, LLC
2022-08-16
EVERFLEX
EVERFLEX
90206371 not registered Live/Pending
Hitachi Vantara LLC
2020-09-24
EVERFLEX
EVERFLEX
88631780 not registered Live/Pending
Maurices Incorporated
2019-09-26
EVERFLEX
EVERFLEX
87935879 not registered Live/Pending
C Products Defense, Inc.
2018-05-24
EVERFLEX
EVERFLEX
87878026 5717631 Live/Registered
teleMovement Physical Therapy, a Professional corporation
2018-04-16
EVERFLEX
EVERFLEX
86418474 4743484 Live/Registered
Ink Cups Now Corporation
2014-10-08
EVERFLEX
EVERFLEX
78803917 3270214 Live/Registered
COVIDIEN LP
2006-01-31
EVERFLEX
EVERFLEX
78004147 not registered Dead/Abandoned
MATTEL, INC.
2000-04-14
EVERFLEX
EVERFLEX
77600830 not registered Dead/Abandoned
Mohawk Brands, Inc.
2008-10-27
EVERFLEX
EVERFLEX
77004810 not registered Dead/Abandoned
Corinthian Colleges, Inc.
2006-09-21
EVERFLEX
EVERFLEX
76624977 not registered Dead/Abandoned
Foamorder.com, Inc.
2004-12-20
EVERFLEX
EVERFLEX
76520007 2917827 Live/Registered
Nature's Sunshine Products, Inc.
2003-06-05
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.