Strata®, Innervision

GUDID 00613994721662

SHUNT 27927 STRATA II SML W/VRES INNERVN

MEDTRONIC PS MEDICAL, INC.

Ventriculoperitoneal shunt Ventriculoperitoneal shunt Ventriculoperitoneal shunt

• Primary Device ID: 00613994721662
• NIH Device Record Key: b71e97ac-8306-4806-a7b7-6a70711eb004
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Strata®, Innervision
• Version Model Number: 27927
• Company DUNS: 089055867
• Company Name: MEDTRONIC PS MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

Device Dimensions

• Length: 120 Centimeter
• Length: 120 Centimeter
• Length: 120 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994721662 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042465

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-06-11

On-Brand Devices [Strata®, Innervision]

• 00613994721662: SHUNT 27927 STRATA II SML W/VRES INNERVN
• 00613994721655: SHUNT 27926 STRATA II REG W/VRES INNERVN