Embozene Color Advance 40um Embozene 2mL Colored - US

GUDID 00810563021066

VARIAN MEDICAL SYSTEMS, INC.

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

• Primary Device ID: 00810563021066
• NIH Device Record Key: e3d1f279-4354-4b39-863c-f4b4c704e746
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Embozene Color Advance 40um Embozene 2mL Colored - US
• Version Model Number: 10420-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	00810563021066 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180102

FDA Product Code

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

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

Devices Manufactured by VARIAN MEDICAL SYSTEMS, INC.

• 00856100006158 - Visual Coaching Device (VCD): 2023-11-22
• 00850800006067 - VariSeed: 2023-09-25
• 00858086006801 - IDENTIFY: 2023-08-14
• 00855141006202 - Eclipse Treatment Planning System: 2023-08-07
• 00899475002042 - Clinac iX: 2023-06-20
• 00899475002066 - Trilogy: 2023-06-20
• 00899475002080 - Novalis Tx: 2023-06-20
• 00810563021066 - Embozene Color Advance 40um Embozene 2mL Colored - US: 2023-05-29
• 00810563021066 - Embozene Color Advance 40um Embozene 2mL Colored - US: 2023-05-29