Innervision, BioGlide®

GUDID 00763000028961

CATH 99102 INNERVISION BIOGLIDE

MEDTRONIC PS MEDICAL, INC.

Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term Intracerebral infusion/drainage catheter, long-term

• Primary Device ID: 00763000028961
• NIH Device Record Key: 99d9c460-dcd1-42f0-8004-ce5f44426bb9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Innervision, BioGlide®
• Version Model Number: 99102
• 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
• 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	00763000028961 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K983331

FDA Product Code

• HCA: CATHETER, VENTRICULAR

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: 2020-08-31
• Device Publish Date: 2020-08-21

On-Brand Devices [Innervision, BioGlide®]

• 00613994908476: KIT 2120-925 INNER/ENDO SHUNT PLCMT BIO
• 00643169472860: CATH 99102 INNERVISION BIOGLIDE
• 00763000028961: CATH 99102 INNERVISION BIOGLIDE