EmboCube™ EC5025

GUDID 10884450306229

BIOSPHERE MEDICAL

Non-neurovascular embolization plug, animal-derived

• Primary Device ID: 10884450306229
• NIH Device Record Key: 912b4835-cab0-4c19-8696-1eb03095e589
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EmboCube™
• Version Model Number: 00884450306222
• Catalog Number: EC5025
• Company DUNS: 635091932
• Company Name: BIOSPHERE MEDICAL
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450306222 [Primary]
GS1	10884450306229 [Package]; Contains: 00884450306222; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181021

FDA Product Code

• KRD: Device, Vascular, for Promoting Embolization

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: 2019-04-01
• Device Publish Date: 2019-03-23

Devices Manufactured by BIOSPHERE MEDICAL

• 10884450403713 - Embosphere®: 2022-10-10
• 10884450403829 - Embosphere®: 2022-10-10
• 10884450093662 - Tenor®: 2022-09-30
• 10884450299439 - Embosphere®: 2022-09-28
• 10884450403058 - Embosphere®: 2019-12-10
• 10884450402945 - Embosphere®: 2019-11-08
• 10884450403133 - Embosphere®: 2019-09-18
• 10884450403423 - Embosphere®: 2019-06-25