GUDID 00643169072664

KIT 8543 ISOMED CAP IP20.1 PUMP US MKT

MEDTRONIC, INC.

Neurosurgical procedure kit, non-medicated, single-use Neurosurgical procedure kit, non-medicated, single-use

• Primary Device ID: 00643169072664
• NIH Device Record Key: 40faf780-fad8-4731-b7d1-4a5c650d2465
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 8543
• Company DUNS: 796986144
• Company Name: MEDTRONIC, 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169072664 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P990034

FDA Product Code

• LKK: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

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: 2014-09-23

Devices Manufactured by MEDTRONIC, INC.

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• 00763000949341 - NA: 2024-05-06 CUSTOM PACK BB12A73R5 AV LOOP
• 20763000949369 - NA: 2024-05-06 CUSTOM PACK BB12F71R2 4PK LOYOLA CPG
• 00763000949372 - NA: 2024-05-06 CUSTOM PACK BB11L23R8 UTMC SUPP PK
• 20763000950105 - NA: 2024-05-06 CUSTOM PACK BB12G65R 5PK TAPER
• 00763000950118 - NA: 2024-05-06 CUSTOM PACK CB3Z71R24 PRIMARY