ISOMED ®

GUDID 00681490184311

KIT 8553 ISOMED DOMESTC

MEDTRONIC, INC.

Neurosurgical procedure kit, non-medicated, single-use

• Primary Device ID: 00681490184311
• NIH Device Record Key: 9ff57a6e-3098-4d80-8d4c-7505ac4e1b45
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ISOMED ®
• Version Model Number: 8553
• 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	00681490184311 [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

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• 00763000984151 - NA: 2024-11-15 CUSTOM PACK BB12F08R2 SPECTRUM ADLT
• 00763000984168 - NA: 2024-11-15 CUSTOM PACK BB12F26R4 MUNSTER FUS
• 00763000984175 - NA: 2024-11-15 CUSTOM PACK BB12F66R6 1/4 EC PACK
• 00763000180010 - Sprint Quattro Secure S™: 2024-11-12 LEAD 693552 SPRINT US RCMCRD
• 00763000180027 - Sprint Quattro Secure S™: 2024-11-12 LEAD 693575 SPRINT US RCMCRD