Wholey WWFS35145

GUDID 00821684049372

Guidewire System;Floppy Tip, Extension Compatible

Covidien LP

Peripheral vascular guidewire, manual

• Primary Device ID: 00821684049372
• NIH Device Record Key: 81a1f76c-1c2d-44e9-babb-dbc4a52ec498
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Wholey
• Version Model Number: WWFS35145
• Catalog Number: WWFS35145
• Company DUNS: 968903703
• Company Name: Covidien LP
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does n
• 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

Device Dimensions

• Outer Diameter: 0.035 Inch
• Length: 145 Centimeter
• Outer Diameter: 0.035 Inch
• Length: 145 Centimeter

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00821684049372 [Package]; Contains: 00821684058602; Package: PK [3 Units]; In Commercial Distribution
GS1	00821684058602 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120863

FDA Product Code

• DQX: WIRE, GUIDE, CATHETER

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: 2017-06-16

On-Brand Devices [Wholey]

• 00821684049389: Guidewire System;Floppy Tip, Extension Compatible
• 00821684049372: Guidewire System;Floppy Tip, Extension Compatible