Opus®

GUDID 00763000029180

CATH 41501 OPUS VENTRICULAR SM 23CM

MEDTRONIC PS MEDICAL, INC.

Intracerebral infusion/drainage catheter, long-term

• Primary Device ID: 00763000029180
• NIH Device Record Key: a48f3dcb-b1aa-4ced-b0e2-dc139f9ea24e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Opus®
• Version Model Number: 41501
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000029180 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K792007

FDA Product Code

• JXG: Shunt, central nervous system and components

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: 2020-03-30
• Device Publish Date: 2020-03-20

On-Brand Devices [Opus®]

• 00643169497184: STYLET 23085 B OPUS PACKAGED STERILE
• 00643169482951: CATH 41501 OPUS VENTRICULAR SM 23CM
• 00643169472358: CATH 41503 OPUS VENTRICULAR STD 23CM
• 00673978227696: CATH 41501 OPUS VENTRICULAR SM 23CM
• 00763000029180: CATH 41501 OPUS VENTRICULAR SM 23CM
• 00763000028541: CATH 41503 OPUS VENTRICULAR STD 23CM