GUDID 20613994885887

WIRE 004455 100PK BNS .038X145 3MMJ PTFE

MEDTRONIC, INC.

Cardiac/peripheral vascular guidewire, single-use

• Primary Device ID: 20613994885887
• NIH Device Record Key: d8752258-8619-4a1b-b94a-2e94f5adc031
• Commercial Distribution Discontinuation: 2017-08-02
• Commercial Distribution Status: Not in Commercial Distribution
• Version Model Number: 004455
• Company DUNS: 006261481
• Company Name: MEDTRONIC, INC.
• Device Count: 100
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place. Do not expose to organic solvents.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place. Do not expose to organic solvents.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994885883 [Unit of Use]
GS1	20613994885887 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082873

FDA Product Code

• DQX: WIRE, GUIDE, CATHETER

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-11

Devices Manufactured by MEDTRONIC, INC.

• 00763000989903 - NA: 2024-12-30 CUSTOM PACK BB12H87R2 3/8 E PACK
• 00763000989729 - NA: 2024-12-27 CUSTOM PACK BB8S01R5 CITRS AVL
• 20763000989754 - NA: 2024-12-27 CUSTOM PACK BB12G31R2 4PK ENOE CPL
• 20763000989846 - NA: 2024-12-27 CUSTOM PACK BB11L70R1 4PK CP 2013
• 00763000708917 - DiamondTemp™ FASTR RF Generator: 2024-12-23 GENERATOR CEDTG200 FASTR RF US
• 00763000709051 - DiamondTemp™ Irrigation Pump: 2024-12-23 IRRIGATION PUMP CEDTP100 US
• 00763000989156 - NA: 2024-12-23 CUSTOM PACK BB11C49R9 1/4 PACK
• 00763000989163 - NA: 2024-12-23 CUSTOM PACK BB12M25R1 TAPER BOOT