Enteer™

GUDID 00821684073841

GW ENW-SF-014-300 CTO RE-ENTRY V03

Covidien LP

Peripheral vascular guidewire, manual

• Primary Device ID: 00821684073841
• NIH Device Record Key: ec4f46ea-e214-46ca-a87d-d8c1665e730f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Enteer™
• Version Model Number: ENW-SF-014-300
• 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

Device Dimensions

• Length: 300 Centimeter
• Length: 300 Centimeter
• Length: 300 Centimeter
• Length: 300 Centimeter
• Outer Diameter: 0.36 Millimeter
• Length: 300 Centimeter
• Outer Diameter: 0.36 Millimeter
• Length: 300 Centimeter
• Outer Diameter: 0.36 Millimeter
• Length: 300 Centimeter
• Outer Diameter: 0.36 Millimeter
• Length: 300 Centimeter
• Outer Diameter: 0.36 Millimeter
• Length: 300 Centimeter
• Outer Diameter: 0.36 Millimeter
• Length: 300 Centimeter
• Outer Diameter: 0.36 Millimeter
• Length: 300 Centimeter
• Outer Diameter: 0.36 Millimeter
• Length: 300 Centimeter
• Outer Diameter: 0.36 Millimeter
• Length: 300 Centimeter
• Outer Diameter: 0.36 Millimeter
• Length: 300 Centimeter
• Outer Diameter: 0.36 Millimeter
• Length: 300 Centimeter
• Outer Diameter: 0.36 Millimeter
• Length: 300 Centimeter
• Outer Diameter: 0.36 Millimeter
• Length: 300 Centimeter
• Outer Diameter: 0.36 Millimeter
• Length: 300 Centimeter

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00821684073841 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120533

FDA Product Code

• PDU: Catheter for crossing total occlusions

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: 2016-09-01

On-Brand Devices [Enteer™]

• 00821684073841: GW ENW-SF-014-300 CTO RE-ENTRY V03
• 00821684073834: GW ENW-SD-014-300 CTO RE-ENTRY V03
• 00821684073827: GW ENW-FX-014-300 CTO RE-ENTRY V03
• 00821684073797: CATH ENB-375-20-135 CTO RE-ENTRY V03
• 00821684073780: CATH ENB-275-20-150 CTO RE-ENTRY V03