EDM

GUDID 00763000030261

EDM 27637 VCATH TRANS OD 4.9MM W/TROC

MEDTRONIC PS MEDICAL, INC.

Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term

• Primary Device ID: 00763000030261
• NIH Device Record Key: fd5184a4-a209-48f9-80bf-5d7d7f18e293
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EDM
• Version Model Number: 27637
• 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
• 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
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000030261 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K802100

FDA Product Code

• GWM: Device, monitoring, intracranial pressure

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: 2020-05-18
• Device Publish Date: 2020-05-08

On-Brand Devices [EDM]

• 00643169497603: CLAMP 46135 QUICK ATTACH POLE
• 00643169497078: EDM 27637 VCATH TRANS OD 4.9MM W/TROC
• 00643169496910: EDM 27659 V/CATHETER 20CM LENGTH MARKER
• 00763000030261: EDM 27637 VCATH TRANS OD 4.9MM W/TROC
• 00763000030148: EDM 27659 V/CATHETER 20CM LENGTH MARKER