Embozene Color Advance 900um Embozene 1mL Colored - US

GUDID 00810563021554

VARIAN MEDICAL SYSTEMS, INC.

Embolization particle, non-bioabsorbable

• Primary Device ID: 00810563021554
• NIH Device Record Key: 21867e7f-81b4-4cd1-a613-7de3c0df9b41
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Embozene Color Advance 900um Embozene 1mL Colored - US
• Version Model Number: 19010-S1
• Company DUNS: 009120817
• Company Name: VARIAN MEDICAL SYSTEMS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00810563021554 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180102

FDA Product Code

• NAJ: Agents, embolic, for treatment of uterine fibroids

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: 2023-05-29
• Device Publish Date: 2023-05-19

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