Solitaire™ X-PACK

GUDID 00763000270476

KIT XPACK313 V01 US

Micro Therapeutics, Inc.

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• Primary Device ID: 00763000270476
• NIH Device Record Key: 3b9041cd-e97c-4221-ba6b-2ffd3dfacc3c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Solitaire™ X-PACK
• Version Model Number: XPACK313
• Company DUNS: 826110710
• Company Name: Micro Therapeutics, 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: true
• 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
• 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	00763000270476 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180715

FDA Product Code

• POL: Neurovascular Mechanical Thrombectomy Device for Acute Ischemic Stroke Treatment

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: 2019-11-15
• Device Publish Date: 2019-11-07

On-Brand Devices [Solitaire™ X-PACK]

• 00763000270810: KIT XPACK347 V01 US
• 00763000270803: KIT XPACK346 V01 US
• 00763000270797: KIT XPACK345 V01 US
• 00763000270780: KIT XPACK344 V01 US
• 00763000270759: KIT XPACK341 V01 US
• 00763000270742: KIT XPACK340 V01 US
• 00763000270735: KIT XPACK339 V01 US
• 00763000270728: KIT XPACK338 V01 US
• 00763000270698: KIT XPACK335 V01 US
• 00763000270681: KIT XPACK334 V01 US
• 00763000270674: KIT XPACK333 V01 US
• 00763000270667: KIT XPACK332 V01 US
• 00763000270650: KIT XPACK331 V01 US
• 00763000270612: KIT XPACK327 V01 US
• 00763000270605: KIT XPACK326 V01 US
• 00763000270599: KIT XPACK325 V01 US
• 00763000270582: KIT XPACK324 V01 US
• 00763000270575: KIT XPACK323 V01 US
• 00763000270513: KIT XPACK317 V01 US
• 00763000270506: KIT XPACK316 V01 US
• 00763000270490: KIT XPACK315 V01 US
• 00763000270483: KIT XPACK314 V01 US
• 00763000270476: KIT XPACK313 V01 US
• 00763000270438: KIT XPACK309 V01 US
• 00763000270421: KIT XPACK308 V01 US
• 00763000270414: KIT XPACK307 V01 US
• 00763000270407: KIT XPACK306 V01 US
• 00763000270391: KIT XPACK305 V01 US
• 00763000270339: KIT XPACK217 V01 US
• 00763000270322: KIT XPACK216 V01 US
• 00763000270315: KIT XPACK215 V01 US
• 00763000270308: KIT XPACK214 V01 US
• 00763000270292: KIT XPACK213 V01 US
• 00763000270254: KIT XPACK209 V01 US
• 00763000270247: KIT XPACK208 V01 US
• 00763000270230: KIT XPACK207 V01 US
• 00763000270223: KIT XPACK206 V01 US
• 00763000270216: KIT XPACK205 V01 US
• 00763000270773: KIT XPACK343 V01 US
• 00763000270766: KIT XPACK342 V01 US
• 00763000270711: KIT XPACK337 V01 US
• 00763000270704: KIT XPACK336 V01 US
• 00763000270568: KIT XPACK322 V01 US
• 00763000270551: KIT XPACK321 V01 US
• 00763000270544: KIT XPACK320 V01 US
• 00763000270537: KIT XPACK319 V01 US
• 00763000270520: KIT XPACK318 V01 US
• 00763000270384: KIT XPACK304 V01 US
• 00763000270377: KIT XPACK303 V01 US
• 00763000270360: KIT XPACK302 V01 US