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

Devices Manufactured by MEDTRONIC, INC.

• 20763000994185 - NA: 2025-02-07 CUSTOM PACK BB8Q17R2 2PK 1/4 X 1/4
• 20763000994246 - NA: 2025-02-07 CUSTOM PACK BB12L75R1 4PK OVP MYO
• 00763000994259 - NA: 2025-02-07 CUSTOM PACK BB11P48R4 ATTRNSFN SET
• 00763000994334 - NA: 2025-02-07 CUSTOM PACK BB6W69R18 ADULT PACK
• 20763000994352 - NA: 2025-02-07 CUSTOM PACK BB3P82R6 10PK VRV LINE
• 00763000994365 - NA: 2025-02-07 CUSTOM PACK BB9R12R17 FUSION PK
• 00763000994464 - NA: 2025-02-07 CUSTOM PACK BB12M85R 1/4 X 3/8
• 00763000994471 - NA: 2025-02-07 CUSTOM PACK BB10V22R9 TAVR PACK