Pipeline TM Flex Embolization Device with Shield Technology TM

GUDID 00763000449377

STENT PED2-450-18 V08 MDR

Micro Therapeutics, Inc.

Bare-metal intracranial vascular stent

• Primary Device ID: 00763000449377
• NIH Device Record Key: 89e30529-1489-4b07-94d9-f6c87601314b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pipeline TM Flex Embolization Device with Shield Technology TM
• Version Model Number: PED2-450-18
• Company DUNS: 826110710
• Company Name: Micro Therapeutics, 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
• 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	00763000449377 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P100018

FDA Product Code

• OUT: Intracranial aneurysm flow diverter

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: 2025-03-18
• Device Publish Date: 2025-03-10

On-Brand Devices [Pipeline TM Flex Embolization Device with Shield Technology TM]

• 00763000449551: STENT PED2-500-18 V08 MDR
• 00763000449544: STENT PED2-500-16 V08 MDR
• 00763000449537: STENT PED2-500-14 V08 MDR
• 00763000449520: STENT PED2-500-12 V08 MDR
• 00763000449513: STENT PED2-500-10 V08 MDR
• 00763000449506: STENT PED2-475-35 V08 MDR
• 00763000449490: STENT PED2-475-30 V08 MDR
• 00763000449483: STENT PED2-475-25 V08 MDR
• 00763000449476: STENT PED2-475-20 V08 MDR
• 00763000449414: STENT PED2-450-35 V08 MDR
• 00763000449391: STENT PED2-450-25 V08 MDR
• 00763000449384: STENT PED2-450-20 V08 MDR
• 00763000449377: STENT PED2-450-18 V08 MDR
• 00763000448998: STENT PED2-350-14 V08 MDR
• 00763000448981: STENT PED2-350-12 V08 MDR
• 00763000448912: STENT PED2-325-16 V08 MDR
• 00763000448905: STENT PED2-325-14 V08 MDR
• 00763000448899: STENT PED2-325-12 V08 MDR
• 00763000448882: STENT PED2-325-10 V08 MDR
• 00763000448875: STENT PED2-300-35 V08 MDR
• 00763000448868: STENT PED2-300-30 V08 MDR
• 00763000448851: STENT PED2-300-25 V08 MDR
• 00763000448844: STENT PED2-300-20 V08 MDR
• 00763000448837: STENT PED2-300-18 V08 MDR
• 00763000448820: STENT PED2-300-16 V08 MDR
• 00763000448813: STENT PED2-300-14 V08 MDR
• 00763000448806: STENT PED2-300-12 V08 MDR
• 00763000448790: STENT PED2-300-10 V08 MDR
• 00763000448783: STENT PED2-275-20 V08 MDR
• 00763000448776: STENT PED2-275-18 V08 MDR
• 00763000448769: STENT PED2-275-16 V08 MDR
• 00763000448752: STENT PED2-275-14 V08 MDR
• 00763000448745: STENT PED2-275-12 V08 MDR
• 00763000448738: STENT PED2-275-10 V08 MDR
• 00763000448721: STENT PED2-250-20 V08 MDR
• 00763000448714: STENT PED2-250-18 V08 MDR
• 00763000448707: STENT PED2-250-16 V08 MDR
• 00763000448691: STENT PED2-250-14 V08 MDR
• 00763000448684: STENT PED2-250-12 V08 MDR
• 00763000448677: STENT PED2-250-10 V08 MDR
• 00763000449599: STENT PED2-500-35 V08 MDR
• 00763000449582: STENT PED2-500-30 V08 MDR
• 00763000449575: STENT PED2-500-25 V08 MDR
• 00763000449568: STENT PED2-500-20 V08 MDR
• 00763000449469: STENT PED2-475-18 V08 MDR
• 00763000449452: STENT PED2-475-16 V08 MDR
• 00763000449445: STENT PED2-475-14 V08 MDR
• 00763000449438: STENT PED2-475-12 V08 MDR
• 00763000449421: STENT PED2-475-10 V08 MDR
• 00763000449407: STENT PED2-450-30 V08 MDR