GUDID 00763000058968

STYLET 6057-45 STRGHT BALL GLBL EIFU

MEDTRONIC, INC.

Pacing/defibrillation lead stylet

• Primary Device ID: 00763000058968
• NIH Device Record Key: c745050d-d04b-4470-96d6-be389603717e
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 6057-45
• 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

Device Dimensions

• Outer Diameter: 0.014 Inch
• Outer Diameter: 0.014 Inch
• Outer Diameter: 0.014 Inch
• Outer Diameter: 0.014 Inch
• Outer Diameter: 0.014 Inch
• Outer Diameter: 0.014 Inch

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000058968 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P830061

FDA Product Code

• DRB: STYLET, CATHETER

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-09-19
• Device Publish Date: 2018-08-19

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