GUDID 00643169472730

KIT 9040 D SHUNT INTL ONLY BH 16MM LOW

MEDTRONIC PS MEDICAL, INC.

Ventriculo-peritoneal/atrial shunt

• Primary Device ID: 00643169472730
• NIH Device Record Key: d6f300b0-3571-437c-95e7-890c59baf12b
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 9040 D
• Company DUNS: 089055867
• Company Name: MEDTRONIC PS MEDICAL, 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

• Length: 90 Centimeter
• Length: 90 Centimeter
• Length: 90 Centimeter
• Length: 90 Centimeter
• Length: 90 Centimeter
• Length: 90 Centimeter
• Length: 90 Centimeter
• Length: 90 Centimeter
• Width: 16 Millimeter
• Outer Diameter: 2.5 Millimeter
• Device Size Text, specify: 0
• Length: 90 Centimeter
• Width: 16 Millimeter
• Outer Diameter: 2.5 Millimeter
• Device Size Text, specify: 0
• Length: 90 Centimeter
• Width: 16 Millimeter
• Outer Diameter: 2.5 Millimeter
• Device Size Text, specify: 0
• Length: 90 Centimeter
• Width: 16 Millimeter
• Outer Diameter: 2.5 Millimeter
• Device Size Text, specify: 0
• Length: 90 Centimeter
• Width: 16 Millimeter
• Outer Diameter: 2.5 Millimeter
• Device Size Text, specify: 0
• Length: 90 Centimeter
• Width: 16 Millimeter
• Outer Diameter: 2.5 Millimeter
• Device Size Text, specify: 0
• Length: 90 Centimeter
• Width: 16 Millimeter
• Outer Diameter: 2.5 Millimeter
• Device Size Text, specify: 0
• Length: 90 Centimeter
• Width: 16 Millimeter
• Outer Diameter: 2.5 Millimeter
• Device Size Text, specify: 0
• Length: 90 Centimeter
• Width: 16 Millimeter
• Outer Diameter: 2.5 Millimeter
• Device Size Text, specify: 0
• Length: 90 Centimeter
• Width: 16 Millimeter
• Outer Diameter: 2.5 Millimeter
• Device Size Text, specify: 0
• Length: 90 Centimeter
• Width: 16 Millimeter
• Outer Diameter: 2.5 Millimeter
• Device Size Text, specify: 0
• Length: 90 Centimeter
• Width: 16 Millimeter
• Outer Diameter: 2.5 Millimeter
• Device Size Text, specify: 0
• Length: 90 Centimeter
• Width: 16 Millimeter
• Outer Diameter: 2.5 Millimeter
• Device Size Text, specify: 0
• Length: 90 Centimeter
• Width: 16 Millimeter
• Outer Diameter: 2.5 Millimeter
• Device Size Text, specify: 0
• Length: 90 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169472730 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K831678

FDA Product Code

• JXG: Shunt, central nervous system and components

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: 2015-06-24

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• 00763000281243 - Exacta Pole Clamp with laser level: 2025-02-25 CLAMP 46715 EXACTA PL NEG 25CM W/LSR
• 00763000281229 - Exacta Pole Clamp with laser level: 2025-02-24 ASSY 46711 EXACTA POLE CLAMP W/LASER
• 00763000413255 - Exacta™: 2025-02-10 ASSY 46711 EXACTA POLE CLAMP W/LASER
• 00763000413262 - Exacta™: 2025-02-10 CLAMP 46715 EXACTA PL NEG 25CM W/LSR
• 00763000422653 - Valve, StrataMR II, Regular: 2025-01-31 ASSY 46965MR SHUNT STRATAMR II REG CE