EverFlex™ Prote´ge´™ EverFlex™

GUDID 00821684060308

STENT PRB35-08-120-120 PROTEGE EF V07

Covidien LP

Multiple peripheral artery stent, bare-metal

Primary Device ID	00821684060308
NIH Device Record Key	ada4d6ab-edd9-4dcc-bbf7-13aa8ee63487
Commercial Distribution Status	In Commercial Distribution
Brand Name	EverFlex™ Prote´ge´™ EverFlex™
Version Model Number	PRB35-08-120-120
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	false
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(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com

Device Dimensions

Length	120 Millimeter
Length	120 Millimeter
Length	120 Millimeter
Length	120 Millimeter
Catheter Gauge	6 French
Length	120 Millimeter
Catheter Gauge	6 French
Length	120 Millimeter
Catheter Gauge	6 French
Length	120 Millimeter
Catheter Gauge	6 French
Length	120 Millimeter
Catheter Gauge	6 French
Length	120 Millimeter
Catheter Gauge	6 French
Length	120 Millimeter
Catheter Gauge	6 French
Length	120 Millimeter
Catheter Gauge	6 French
Length	120 Millimeter
Catheter Gauge	6 French
Length	120 Millimeter
Catheter Gauge	6 French
Length	120 Millimeter
Catheter Gauge	6 French
Length	120 Millimeter
Catheter Gauge	6 French
Length	120 Millimeter
Catheter Gauge	6 French
Length	120 Millimeter
Catheter Gauge	6 French
Length	120 Millimeter
Catheter Gauge	6 French
Length	120 Millimeter
Catheter Gauge	6 French
Length	120 Millimeter
Catheter Gauge	6 French
Length	120 Millimeter
Catheter Gauge	6 French
Length	120 Millimeter
Catheter Gauge	6 French
Length	120 Millimeter
Catheter Gauge	6 French
Length	120 Millimeter
Catheter Gauge	6 French
Length	120 Millimeter
Catheter Gauge	6 French
Length	120 Millimeter
Catheter Gauge	6 French
Length	120 Millimeter
Catheter Gauge	6 French
Length	120 Millimeter
Catheter Gauge	6 French
Length	120 Millimeter
Catheter Gauge	6 French
Length	120 Millimeter
Catheter Gauge	6 French
Length	120 Millimeter
Catheter Gauge	6 French
Length	120 Millimeter
Catheter Gauge	6 French
Length	120 Millimeter
Catheter Gauge	6 French
Length	120 Millimeter
Catheter Gauge	6 French
Length	120 Millimeter
Catheter Gauge	6 French
Length	120 Millimeter
Catheter Gauge	6 French
Length	120 Millimeter
Catheter Gauge	6 French
Length	120 Millimeter
Catheter Gauge	6 French
Length	120 Millimeter
Catheter Gauge	6 French
Length	120 Millimeter
Catheter Gauge	6 French
Length	120 Millimeter
Catheter Gauge	6 French
Length	120 Millimeter
Catheter Gauge	6 French
Length	120 Millimeter
Catheter Gauge	6 French
Length	120 Millimeter
Catheter Gauge	6 French
Length	120 Millimeter
Catheter Gauge	6 French
Length	120 Millimeter
Catheter Gauge	6 French
Length	120 Millimeter
Catheter Gauge	6 French
Length	120 Millimeter
Catheter Gauge	6 French
Length	120 Millimeter
Catheter Gauge	6 French
Length	120 Millimeter
Catheter Gauge	6 French
Length	120 Millimeter
Catheter Gauge	6 French
Length	120 Millimeter
Catheter Gauge	6 French
Length	120 Millimeter
Catheter Gauge	6 French
Length	120 Millimeter

Operating and Storage Conditions

Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	00821684060308 [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	2016-02-15

On-Brand Devices [EverFlex™ Prote´ge´™ EverFlex™]

00821684060339	STENT PRB35-08-200-120 PROTEGE EF V07
00821684060322	STENT PRB35-08-150-120 PROTEGE EF V07
00821684060315	STENT PRB35-08-150-080 PROTEGE EF V07
00821684060308	STENT PRB35-08-120-120 PROTEGE EF V07
00821684060292	STENT PRB35-08-120-080 PROTEGE EF V07
00821684060285	STENT PRB35-08-100-120 PROTEGE EF V07
00821684060278	STENT PRB35-08-100-080 PROTEGE EF V07
00821684060261	STENT PRB35-08-080-120 PROTEGE EF V07
00821684060254	STENT PRB35-08-080-080 PROTEGE EF V07
00821684060247	STENT PRB35-08-060-120 PROTEGE EF V07
00821684060230	STENT PRB35-08-060-080 PROTEGE EF V07
00821684060223	STENT PRB35-08-040-120 PROTEGE EF V07
00821684060216	STENT PRB35-08-040-080 PROTEGE EF V07
00821684060209	STENT PRB35-08-030-120 PROTEGE EF V07
00821684060193	STENT PRB35-08-030-080 PROTEGE EF V07
00821684060186	STENT PRB35-08-020-120 PROTEGE EF V07
00821684060179	STENT PRB35-08-020-080 PROTEGE EF V07
00821684060162	STENT PRB35-07-200-120 PROTEGE EF V07
00821684060155	STENT PRB35-07-150-120 PROTEGE EF V07
00821684060148	STENT PRB35-07-150-080 PROTEGE EF V07
00821684060131	STENT PRB35-07-120-120 PROTEGE EF V07
00821684060124	STENT PRB35-07-120-080 PROTEGE EF V07
00821684060117	STENT PRB35-07-100-120 PROTEGE EF V07
00821684060100	STENT PRB35-07-100-080 PROTEGE EF V07
00821684060094	STENT PRB35-07-080-120 PROTEGE EF V07
00821684060087	STENT PRB35-07-080-080 PROTEGE EF V07
00821684060070	STENT PRB35-07-060-120 PROTEGE EF V07
00821684060063	STENT PRB35-07-060-080 PROTEGE EF V07
00821684060056	STENT PRB35-07-040-120 PROTEGE EF V07
00821684060049	STENT PRB35-07-040-080 PROTEGE EF V07
00821684060032	STENT PRB35-07-030-120 PROTEGE EF V07
00821684060025	STENT PRB35-07-030-080 PROTEGE EF V07
00821684060018	STENT PRB35-07-020-120 PROTEGE EF V07
00821684060001	STENT PRB35-07-020-080 PROTEGE EF V07
00821684059999	STENT PRB35-06-200-120 PROTEGE EF V07
00821684059982	STENT PRB35-06-150-120 PROTEGE EF V07
00821684059975	STENT PRB35-06-150-080 PROTEGE EF V07
00821684059968	STENT PRB35-06-120-120 PROTEGE EF V07
00821684059951	STENT PRB35-06-120-080 PROTEGE EF V07
00821684059944	STENT PRB35-06-100-120 PROTEGE EF V07
00821684059937	STENT PRB35-06-100-080 PROTEGE EF V07
00821684059920	STENT PRB35-06-080-120 PROTEGE EF V07
00821684059913	STENT PRB35-06-080-080 PROTEGE EF V07
00821684059906	STENT PRB35-06-060-120 PROTEGE EF V07
00821684059890	STENT PRB35-06-060-080 PROTEGE EF V07
00821684059883	STENT PRB35-06-040-120 PROTEGE EF V07
00821684059876	STENT PRB35-06-040-080 PROTEGE EF V07
00821684059869	STENT PRB35-06-030-120 PROTEGE EF V07
00821684059852	STENT PRB35-06-030-080 PROTEGE EF V07
00821684059845	STENT PRB35-06-020-120 PROTEGE EF V07

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