EverFlex EVD35-06200120

GUDID 00821684051405

Self-expanding Peripheral Stent with Entrust Delivery System

Covidien LP

Multiple peripheral artery stent, bare-metal

• Primary Device ID: 00821684051405
• NIH Device Record Key: 79a83c52-ec96-4e4d-bf9f-41583b537363
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EverFlex
• Version Model Number: EVD35-06200120
• Catalog Number: EVD35-06200120
• 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

Device Dimensions

• Outer Diameter: 6 Millimeter
• Outer Diameter: 6 Millimeter
• Outer Diameter: 6 Millimeter
• Outer Diameter: 6 Millimeter
• Outer Diameter: 6 Millimeter
• Outer Diameter: 6 Millimeter
• Outer Diameter: 6 Millimeter
• Outer Diameter: 6 Millimeter
• Device Size Text, specify: 0
• Length: 200 Millimeter
• Catheter Gauge: 5 French
• Outer Diameter: 6 Millimeter
• Device Size Text, specify: 0
• Length: 200 Millimeter
• Catheter Gauge: 5 French
• Outer Diameter: 6 Millimeter
• Device Size Text, specify: 0
• Length: 200 Millimeter
• Catheter Gauge: 5 French
• Outer Diameter: 6 Millimeter
• Device Size Text, specify: 0
• Length: 200 Millimeter
• Catheter Gauge: 5 French
• Outer Diameter: 6 Millimeter
• Device Size Text, specify: 0
• Length: 200 Millimeter
• Catheter Gauge: 5 French
• Outer Diameter: 6 Millimeter
• Device Size Text, specify: 0
• Length: 200 Millimeter
• Catheter Gauge: 5 French
• Outer Diameter: 6 Millimeter
• Device Size Text, specify: 0
• Length: 200 Millimeter
• Catheter Gauge: 5 French
• Outer Diameter: 6 Millimeter
• Device Size Text, specify: 0
• Length: 200 Millimeter
• Catheter Gauge: 5 French
• Outer Diameter: 6 Millimeter
• Device Size Text, specify: 0
• Length: 200 Millimeter
• Catheter Gauge: 5 French
• Outer Diameter: 6 Millimeter
• Device Size Text, specify: 0
• Length: 200 Millimeter
• Catheter Gauge: 5 French
• Outer Diameter: 6 Millimeter
• Device Size Text, specify: 0
• Length: 200 Millimeter
• Catheter Gauge: 5 French
• Outer Diameter: 6 Millimeter
• Device Size Text, specify: 0
• Length: 200 Millimeter
• Catheter Gauge: 5 French
• Outer Diameter: 6 Millimeter
• Device Size Text, specify: 0
• Length: 200 Millimeter
• Catheter Gauge: 5 French
• Outer Diameter: 6 Millimeter
• Device Size Text, specify: 0
• Length: 200 Millimeter
• Catheter Gauge: 5 French
• Outer Diameter: 6 Millimeter
• Device Size Text, specify: 0
• Length: 200 Millimeter
• Catheter Gauge: 5 French
• Outer Diameter: 6 Millimeter
• Device Size Text, specify: 0
• Length: 200 Millimeter
• Catheter Gauge: 5 French
• Outer Diameter: 6 Millimeter
• Device Size Text, specify: 0
• Length: 200 Millimeter
• Catheter Gauge: 5 French
• Outer Diameter: 6 Millimeter
• Device Size Text, specify: 0
• Length: 200 Millimeter
• Catheter Gauge: 5 French
• Outer Diameter: 6 Millimeter
• Device Size Text, specify: 0
• Length: 200 Millimeter
• Catheter Gauge: 5 French
• Outer Diameter: 6 Millimeter
• Device Size Text, specify: 0
• Length: 200 Millimeter
• Catheter Gauge: 5 French
• Outer Diameter: 6 Millimeter
• Device Size Text, specify: 0
• Length: 200 Millimeter
• Catheter Gauge: 5 French
• Outer Diameter: 6 Millimeter
• Device Size Text, specify: 0
• Length: 200 Millimeter
• Catheter Gauge: 5 French
• Outer Diameter: 6 Millimeter
• Device Size Text, specify: 0
• Length: 200 Millimeter
• Catheter Gauge: 5 French
• Outer Diameter: 6 Millimeter
• Device Size Text, specify: 0
• Length: 200 Millimeter
• Catheter Gauge: 5 French
• Outer Diameter: 6 Millimeter
• Device Size Text, specify: 0
• Length: 200 Millimeter
• Catheter Gauge: 5 French
• Outer Diameter: 6 Millimeter
• Device Size Text, specify: 0
• Length: 200 Millimeter
• Catheter Gauge: 5 French
• Outer Diameter: 6 Millimeter
• Device Size Text, specify: 0
• Length: 200 Millimeter
• Catheter Gauge: 5 French
• Outer Diameter: 6 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00821684051405 [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: 2016-04-04

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