Ventriculostomy Kit

GUDID 00673978947402

KIT 46156 VENTRICULOSTOMY STANDARD

MEDTRONIC PS MEDICAL, INC.

Manual surgical rotary handpiece

• Primary Device ID: 00673978947402
• NIH Device Record Key: 38313a3a-f3fe-4b39-a697-a55dff93282a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ventriculostomy Kit
• Version Model Number: 46156
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00673978947402 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K915546

FDA Product Code

• HBG: DRILLS, BURRS, TREPHINES & ACCESSORIES (MANUAL)

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: 2016-06-13

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• 00763000467401 - NA: 2024-06-10 CONNECTOR 9041 LUERLOCK TO FIT 1.3MM ID
• 00763000529338 - Becker External Drainage and Monitoring System: 2024-05-27 BECKER 27761 STOP BCNDLESS PATLN 24
• 00763000406073 - Becker: 2024-04-08 EDMS 46128 BECKER II BLUE PT LN
• 00763000467340 - NA: 2024-03-11 KIT 46442 EDM LUMBAR DRN CLS TIP 5PK
• 00763000406042 - NA: 2024-03-05 ASSEMBLY 46422 EDM DRAINAGE