GUDID 00613994663146

NEEDLE EP003994S BROCKENBROUGH ADULT

MEDTRONIC, INC.

Cardiac transseptal needle

• Primary Device ID: 00613994663146
• NIH Device Record Key: d71c61f6-8a65-40e7-9939-662768a384ad
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: EP003994S
• Company DUNS: 006261481
• Company Name: MEDTRONIC, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: 1.02 Millimeter
• Outer Diameter: 1.02 Millimeter
• Outer Diameter: 1.02 Millimeter
• Outer Diameter: 1.02 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994663146 [Primary]

FDA Product Code

• DRC: Trocar

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-04-10

Devices Manufactured by MEDTRONIC, INC.

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• 00763000988258 - NA: 2024-12-20 CUSTOM PACK BB10Q85R1 FILTER
• 00763000988760 - NA: 2024-12-20 CUSTOM PACK BB1F66R26 CASPER
• 00763000973391 - Sphere-9™ Catheter: 2024-12-16 CATHETER AFR-00001 SPHERE 9 Q-US AFR
• 00763000986704 - NA: 2024-12-09 CUSTOM PACK BB7J97R20 1/4 PED CIRC
• 00763000986773 - NA: 2024-12-09 CUSTOM PACK BB11N26R12 MASTER PACK
• 20763000986814 - NA: 2024-12-09 CUSTOM PACK BB12G70R3 10PK SUPPLIES