GUDID 00721902015946

NEEDLE EP003997S BROCKEN 56CM STER 10L

MEDTRONIC, INC.

Cardiac transseptal needle

• Primary Device ID: 00721902015946
• NIH Device Record Key: 03e49aa7-04e3-47b5-b159-57aa21632d6d
• Commercial Distribution Discontinuation: 2018-06-21
• Commercial Distribution Status: Not in Commercial Distribution
• Version Model Number: EP003997S
• 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: 0.912 Millimeter
• Outer Diameter: 0.912 Millimeter
• Outer Diameter: 0.912 Millimeter
• Outer Diameter: 0.912 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	00721902015946 [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: 3
• Public Version Date: 2018-06-28
• Device Publish Date: 2016-04-23

Devices Manufactured by MEDTRONIC, INC.

• 20199150016765 - NA: 2025-05-19 CUSTOM PACK BB10N39R1 10PK 1/2 RACE
• 00199150016778 - NA: 2025-05-19 CUSTOM PACK BB12B71R3 UAB SPECTRUM
• 00199150016785 - NA: 2025-05-19 CUSTOM PACK BB10Y68R5 3/8HEARTASST
• 20199150018103 - NA: 2025-05-19 CUSTOM PACK BB12N40R1 2PK PERF TECH SIN
• 20199150018172 - NA: 2025-05-19 CUSTOM PACK BB11A50R2 5PK 1/4 SUPP PACK
• 00199150018116 - NA: 2025-05-16 CUSTOM PACK BB7C11R6 3/83/8AVL
• 00199150018123 - NA: 2025-05-16 CUSTOM PACK BB2W85R21 MEMBRANE
• 00199150018741 - NA: 2025-05-16 CUSTOM PACK BB7J97R21 1/4 PED CIRC