Confida™

GUDID 20643169357055

GUIDEWIRE GWBC30 CONFIDA 26L

MEDTRONIC, INC.

Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use

• Primary Device ID: 20643169357055
• NIH Device Record Key: 499c4763-c1a9-4400-ba83-64a29feec173
• Commercial Distribution Discontinuation: 2018-10-05
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Confida™
• Version Model Number: GWBC30
• Company DUNS: 006261481
• Company Name: MEDTRONIC, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: false
• 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

Device Dimensions

• Outer Diameter: 0.89 Millimeter
• Outer Diameter: 0.89 Millimeter
• Outer Diameter: 0.89 Millimeter
• Outer Diameter: 0.89 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to organic solvents.
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to organic solvents.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169357051 [Primary]
GS1	20643169357055 [Package]; Contains: 00643169357051; Package: PK [5 Units]; Discontinued: 2018-10-05; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132623

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: 4
• Public Version Date: 2018-12-11
• Device Publish Date: 2016-07-23

On-Brand Devices [Confida™]

• 20643169583737: GUIDEWIRE GWBC30 CONFIDA 29L
• 20643169357055: GUIDEWIRE GWBC30 CONFIDA 26L
• 20763000060880: GUIDEWIRE GWBC30 CONFIDA 29L 3YSL
• 00763000233815: SHEATH CES122230 CONFIDA US 1YSL