QuadraSphere Q2™ V125QS/A

GUDID 10884450299491

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: 10884450299491
• NIH Device Record Key: 985d2c8e-3ce1-40cd-be32-21db40c5666a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QuadraSphere Q2™
• Version Model Number: 00884450299494
• Catalog Number: V125QS/A
• 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: true
• 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	00884450299494 [Primary]
GS1	10884450299491 [Package]; Contains: 00884450299494; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172372

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: 4
• Public Version Date: 2019-03-22
• Device Publish Date: 2017-12-18

Devices Manufactured by BIOSPHERE MEDICAL

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• 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