Embosphere Pro™ S420PRO

GUDID 00884450299456

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: 00884450299456
• NIH Device Record Key: afcb962f-5141-4172-99d4-89254ac53f55
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Embosphere Pro™
• Version Model Number: 00884450299456
• Catalog Number: S420PRO
• 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: true
• 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	00884450299456 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN160040

FDA Product Code

• NOY: Agents, embolic, for treatment of benign prostatic hyperplasia

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-12-18

On-Brand Devices [Embosphere Pro™]

• 00884450299456: 00884450299456
• 10884450299446: 00884450299449