EmboGold®

GUDID 10884450106416

BIOSPHERE MEDICAL

Embolization particle, non-bioabsorbable

• Primary Device ID: 10884450106416
• NIH Device Record Key: 9a10a2f5-85d1-4cc2-ae8d-228acbf3c87f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EmboGold®
• Version Model Number: 00884450106419
• 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	00884450106419 [Primary]
GS1	10884450106416 [Package]; Contains: 00884450106419; Package: [5 Units]; In Commercial Distribution

FDA Product Code

• HCG: DEVICE, NEUROVASCULAR 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 [EmboGold®]

• 10884450122393: 00884450122396
• 10884450119768: 00884450119761
• 10884450118563: 00884450118566
• 10884450118198: 00884450118191
• 10884450112851: 00884450112854
• 10884450110291: 00884450110294
• 10884450106416: 00884450106419
• 10884450103392: 00884450103395
• 10884450100513: 00884450100516
• 10884450097028: 00884450097021
• 10884450096144: 00884450096147