QuadraSphere®

GUDID 10884450106096

BIOSPHERE MEDICAL

Embolization particle, non-bioabsorbable Embolization particle, non-bioabsorbable Embolization particle, non-bioabsorbable Embolization particle, non-bioabsorbable Embolization particle, non-bioabsorbable Embolization particle, non-bioabsorbable Embolization particle, non-bioabsorbable Embolization particle, non-bioabsorbable Embolization particle, non-bioabsorbable Embolization particle, non-bioabsorbable Embolization particle, non-bioabsorbable

• Primary Device ID: 10884450106096
• NIH Device Record Key: 9746f369-717b-4532-82ae-9750d2cf55ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QuadraSphere®
• Version Model Number: 00884450106099
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450106099 [Primary]
GS1	10884450106096 [Package]; Contains: 00884450106099; Package: [1 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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-10-31

On-Brand Devices [QuadraSphere®]

• 10884450275198: 00884450275191
• 10884450275181: 00884450275184
• 10884450275174: 00884450275177
• 10884450275167: 00884450275160
• 10884450118945: 00884450118948
• 10884450118464: 00884450118467
• 10884450113872: 00884450113875
• 10884450106096: 00884450106099