EverFlex PRB35-07-100-120

GUDID 00821684034309

Self-Expanding Peripheral Stent System

Covidien LP

Multiple peripheral artery stent, bare-metal

Primary Device ID	00821684034309
NIH Device Record Key	86f8e6cb-3a4d-47e2-bc61-5e41aca5b004
Commercial Distribution Status	In Commercial Distribution
Brand Name	EverFlex
Version Model Number	PRB35-07-100-120
Catalog Number	PRB35-07-100-120
Company DUNS	968903703
Company Name	Covidien LP
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

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

Device Dimensions

Outer Diameter	7 Millimeter
Outer Diameter	7 Millimeter
Outer Diameter	7 Millimeter
Outer Diameter	7 Millimeter
Outer Diameter	7 Millimeter
Outer Diameter	7 Millimeter
Outer Diameter	7 Millimeter
Outer Diameter	7 Millimeter
Outer Diameter	7 Millimeter
Outer Diameter	7 Millimeter
Length	100 Millimeter
Outer Diameter	2 Millimeter
Device Size Text, specify	0
Catheter Gauge	6 French
Outer Diameter	7 Millimeter
Length	100 Millimeter
Outer Diameter	2 Millimeter
Device Size Text, specify	0
Catheter Gauge	6 French
Outer Diameter	7 Millimeter
Length	100 Millimeter
Outer Diameter	2 Millimeter
Device Size Text, specify	0
Catheter Gauge	6 French
Outer Diameter	7 Millimeter
Length	100 Millimeter
Outer Diameter	2 Millimeter
Device Size Text, specify	0
Catheter Gauge	6 French
Outer Diameter	7 Millimeter
Length	100 Millimeter
Outer Diameter	2 Millimeter
Device Size Text, specify	0
Catheter Gauge	6 French
Outer Diameter	7 Millimeter
Length	100 Millimeter
Outer Diameter	2 Millimeter
Device Size Text, specify	0
Catheter Gauge	6 French
Outer Diameter	7 Millimeter
Length	100 Millimeter
Outer Diameter	2 Millimeter
Device Size Text, specify	0
Catheter Gauge	6 French
Outer Diameter	7 Millimeter
Length	100 Millimeter
Outer Diameter	2 Millimeter
Device Size Text, specify	0
Catheter Gauge	6 French
Outer Diameter	7 Millimeter
Length	100 Millimeter
Outer Diameter	2 Millimeter
Device Size Text, specify	0
Catheter Gauge	6 French
Outer Diameter	7 Millimeter
Length	100 Millimeter
Outer Diameter	2 Millimeter
Device Size Text, specify	0
Catheter Gauge	6 French
Outer Diameter	7 Millimeter
Length	100 Millimeter
Outer Diameter	2 Millimeter
Device Size Text, specify	0
Catheter Gauge	6 French
Outer Diameter	7 Millimeter
Length	100 Millimeter
Outer Diameter	2 Millimeter
Device Size Text, specify	0
Catheter Gauge	6 French
Outer Diameter	7 Millimeter
Length	100 Millimeter
Outer Diameter	2 Millimeter
Device Size Text, specify	0
Catheter Gauge	6 French
Outer Diameter	7 Millimeter
Length	100 Millimeter
Outer Diameter	2 Millimeter
Device Size Text, specify	0
Catheter Gauge	6 French
Outer Diameter	7 Millimeter
Length	100 Millimeter
Outer Diameter	2 Millimeter
Device Size Text, specify	0
Catheter Gauge	6 French
Outer Diameter	7 Millimeter
Length	100 Millimeter
Outer Diameter	2 Millimeter
Device Size Text, specify	0
Catheter Gauge	6 French
Outer Diameter	7 Millimeter
Length	100 Millimeter
Outer Diameter	2 Millimeter
Device Size Text, specify	0
Catheter Gauge	6 French
Outer Diameter	7 Millimeter
Length	100 Millimeter
Outer Diameter	2 Millimeter
Device Size Text, specify	0
Catheter Gauge	6 French
Outer Diameter	7 Millimeter
Length	100 Millimeter
Outer Diameter	2 Millimeter
Device Size Text, specify	0
Catheter Gauge	6 French
Outer Diameter	7 Millimeter
Length	100 Millimeter
Outer Diameter	2 Millimeter
Device Size Text, specify	0
Catheter Gauge	6 French
Outer Diameter	7 Millimeter
Length	100 Millimeter
Outer Diameter	2 Millimeter
Device Size Text, specify	0
Catheter Gauge	6 French
Outer Diameter	7 Millimeter
Length	100 Millimeter
Outer Diameter	2 Millimeter
Device Size Text, specify	0
Catheter Gauge	6 French
Outer Diameter	7 Millimeter
Length	100 Millimeter
Outer Diameter	2 Millimeter
Device Size Text, specify	0
Catheter Gauge	6 French
Outer Diameter	7 Millimeter
Length	100 Millimeter
Outer Diameter	2 Millimeter
Device Size Text, specify	0
Catheter Gauge	6 French
Outer Diameter	7 Millimeter
Length	100 Millimeter
Outer Diameter	2 Millimeter
Device Size Text, specify	0
Catheter Gauge	6 French
Outer Diameter	7 Millimeter
Length	100 Millimeter
Outer Diameter	2 Millimeter
Device Size Text, specify	0
Catheter Gauge	6 French
Outer Diameter	7 Millimeter
Length	100 Millimeter
Outer Diameter	2 Millimeter
Device Size Text, specify	0
Catheter Gauge	6 French
Outer Diameter	7 Millimeter
Length	100 Millimeter
Outer Diameter	2 Millimeter
Device Size Text, specify	0
Catheter Gauge	6 French
Outer Diameter	7 Millimeter
Length	100 Millimeter
Outer Diameter	2 Millimeter
Device Size Text, specify	0
Catheter Gauge	6 French
Outer Diameter	7 Millimeter
Length	100 Millimeter
Outer Diameter	2 Millimeter
Device Size Text, specify	0
Catheter Gauge	6 French
Outer Diameter	7 Millimeter
Length	100 Millimeter
Outer Diameter	2 Millimeter
Device Size Text, specify	0
Catheter Gauge	6 French
Outer Diameter	7 Millimeter
Length	100 Millimeter
Outer Diameter	2 Millimeter
Device Size Text, specify	0
Catheter Gauge	6 French
Outer Diameter	7 Millimeter
Length	100 Millimeter
Outer Diameter	2 Millimeter
Device Size Text, specify	0
Catheter Gauge	6 French
Outer Diameter	7 Millimeter
Length	100 Millimeter
Outer Diameter	2 Millimeter
Device Size Text, specify	0
Catheter Gauge	6 French
Outer Diameter	7 Millimeter
Length	100 Millimeter
Outer Diameter	2 Millimeter
Device Size Text, specify	0
Catheter Gauge	6 French
Outer Diameter	7 Millimeter
Length	100 Millimeter
Outer Diameter	2 Millimeter
Device Size Text, specify	0
Catheter Gauge	6 French
Outer Diameter	7 Millimeter
Length	100 Millimeter
Outer Diameter	2 Millimeter
Device Size Text, specify	0
Catheter Gauge	6 French
Outer Diameter	7 Millimeter
Length	100 Millimeter
Outer Diameter	2 Millimeter
Device Size Text, specify	0
Catheter Gauge	6 French
Outer Diameter	7 Millimeter
Length	100 Millimeter
Outer Diameter	2 Millimeter
Device Size Text, specify	0
Catheter Gauge	6 French
Outer Diameter	7 Millimeter
Length	100 Millimeter
Outer Diameter	2 Millimeter
Device Size Text, specify	0
Catheter Gauge	6 French
Outer Diameter	7 Millimeter
Length	100 Millimeter
Outer Diameter	2 Millimeter
Device Size Text, specify	0
Catheter Gauge	6 French
Outer Diameter	7 Millimeter
Length	100 Millimeter
Outer Diameter	2 Millimeter
Device Size Text, specify	0
Catheter Gauge	6 French
Outer Diameter	7 Millimeter
Length	100 Millimeter
Outer Diameter	2 Millimeter
Device Size Text, specify	0
Catheter Gauge	6 French
Outer Diameter	7 Millimeter
Length	100 Millimeter
Outer Diameter	2 Millimeter
Device Size Text, specify	0
Catheter Gauge	6 French
Outer Diameter	7 Millimeter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00821684034309 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Approval: P110023

FDA Product Code

NIP	STENT, SUPERFICIAL FEMORAL ARTERY

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2014-09-22

On-Brand Devices [EverFlex]

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

Trademark Results [EverFlex]

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