EmboCube® EC5050

GUDID 10884450306236

BIOSPHERE MEDICAL

Non-neurovascular embolization plug, animal-derived

• Primary Device ID: 10884450306236
• NIH Device Record Key: 454979ba-4979-48d6-9425-83b21e56268c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EmboCube®
• Version Model Number: Initial Release
• Catalog Number: EC5050
• 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: true
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450306239 [Primary]
GS1	10884450306236 [Package]; Contains: 00884450306239; Package: [5 Units]; In Commercial Distribution

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: 2026-01-23
• Device Publish Date: 2026-01-15

On-Brand Devices [EmboCube®]

• 10884450306243: Initial Release
• 10884450306236: Initial Release
• 10884450306212: Initial Release
• 10884450306205: Initial Release