THUNDER®

GUDID 00643169452275

GDWR THNDR190J THUNDER 5PK 190 J SIL

MEDTRONIC, INC.

Cardiac/peripheral vascular guidewire, single-use

• Primary Device ID: 00643169452275
• NIH Device Record Key: 87934c14-7f3e-45be-b700-3a4accafba28
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: THUNDER®
• Version Model Number: THNDR190J
• Company DUNS: 006261481
• Company Name: MEDTRONIC, INC.
• 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

• Outer Diameter: 0.014 Inch
• Outer Diameter: 0.014 Inch
• Outer Diameter: 0.014 Inch
• Outer Diameter: 0.014 Inch
• Length: 190 Centimeter
• Outer Diameter: 0.014 Inch
• Length: 190 Centimeter
• Outer Diameter: 0.014 Inch
• Length: 190 Centimeter
• Outer Diameter: 0.014 Inch
• Length: 190 Centimeter
• Outer Diameter: 0.014 Inch
• Length: 190 Centimeter
• Outer Diameter: 0.014 Inch
• Length: 190 Centimeter
• Outer Diameter: 0.014 Inch
• Length: 190 Centimeter
• Outer Diameter: 0.014 Inch
• Length: 190 Centimeter
• Outer Diameter: 0.014 Inch
• Length: 190 Centimeter
• Outer Diameter: 0.014 Inch
• Length: 190 Centimeter
• Outer Diameter: 0.014 Inch
• Length: 190 Centimeter
• Outer Diameter: 0.014 Inch
• Length: 190 Centimeter
• Outer Diameter: 0.014 Inch
• Length: 190 Centimeter
• Outer Diameter: 0.014 Inch
• Length: 190 Centimeter
• Outer Diameter: 0.014 Inch

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169452275 [Primary]
GS1	20643169452279 [Package]; Package: PK [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140695

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: 2016-09-12

On-Brand Devices [THUNDER®]

• 20643169453023: GDWR THNDR190S THUNDER 5PK 190 ST SIL
• 20643169453016: GDWR THNDR300J THUNDER 5PK 300 J SIL
• 20643169453009: GDWR THNDR300S THUNDER 5PK 300 ST SIL
• 20643169452347: GDWR LVTNDR190S THNDR CRM 5PK 190 ST SIL
• 00643169452275: GDWR THNDR190J THUNDER 5PK 190 J SIL
• 20763000569390: GDWR THNDR190S THUNDER 5PK 190 ST SIL
• 20763000569383: GDWR THNDR300J THUNDER 5PK 300 J SIL
• 20763000569376: GDWR THNDR300S THUNDER 5PK 300 ST SIL
• 20763000569369: GDWR THNDR190J THUNDER 5PK 190 J SIL