Strata®, BioGlide®

GUDID 00643169472983

SHUNT 27787 STRATA NSC UNI-KIT REG BIOGL

MEDTRONIC PS MEDICAL, INC.

Ventriculoperitoneal shunt

• Primary Device ID: 00643169472983
• NIH Device Record Key: cb377293-4f81-45bd-97a2-8ed3a1dd9b2a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Strata®, BioGlide®
• Version Model Number: 27787
• 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: 60 Centimeter
• Length: 60 Centimeter
• Length: 60 Centimeter
• Length: 60 Centimeter
• Length: 60 Centimeter
• Length: 60 Centimeter
• Length: 13.5 Centimeter
• Length: 90 Centimeter
• Length: 60 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169472983 [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®, BioGlide®]

• 00643169010833: UNT 27825 STRATA II UNI REG BIO
• 00643169010505: SHUNT 27818 STRATA II SML BIO
• 00643169010499: SHUNT 27819 STRATA II REG BIO
• 00643169010468: SHUNT 27822 STRATA II SNP ASSY SM BIO
• 00643169010451: SHUNT 27823 STRATA II ASSY SNP REG BIO
• 00643169010420: VALVE 92856 FP STRATA 2 SML BG
• 00643169010413: VALVE 92866 FP STRATA 2 REG BG
• 00643169010406: SHUNT 96655 STRATA NSC ASSY SML BIOGLIDE
• 00643169010185: VALVE 92355 STRATA NSC SML BIOGLIDE
• 00643169472990: SHUNT 27786 STRATA NSC UNI-KIT SML BIOGL
• 00643169472983: SHUNT 27787 STRATA NSC UNI-KIT REG BIOGL
• 00643169472952: VALVE 92365 STRATA NSC REG BIOGLIDE
• 00643169472945: SHUNT 96655 STRATA NSC ASSY SML BIOGLIDE
• 00643169472938: SHUNT 96665 STRATA NSC ASSY REG BIOGLIDE
• 00643169466265: VALVE 92355 STRATA NSC SML BIOGLIDE
• 00885074228150: SHUNT 27787 STRATA NSC UNI-KIT REG BIOGL
• 00885074228112: VALVE 92365 STRATA NSC REG BIOGLIDE
• 00763000027360: SHUNT 27822 STRATA II SNP ASSY SM BIO
• 00763000027353: SHUNT 27823 STRATA II ASSY SNP REG BIO