Embozene Microspheres (Color-Advanced)

GUDID 00879397000142

Microspheres for Embolization

CELONOVA BIOSCIENCES, INC.

Embolization particle, non-bioabsorbable

• Primary Device ID: 00879397000142
• NIH Device Record Key: a44560b1-5405-4a92-901d-fc3239136a76
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Embozene Microspheres (Color-Advanced)
• Version Model Number: 10720-S1
• Company DUNS: 168593429
• Company Name: CELONOVA BIOSCIENCES, INC.
• 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

• Outer Diameter: 75 Micrometer
• Outer Diameter: 75 Micrometer
• Outer Diameter: 75 Micrometer
• Outer Diameter: 75 Micrometer
• Outer Diameter: 75 Micrometer
• Outer Diameter: 75 Micrometer
• Outer Diameter: 75 Micrometer
• Outer Diameter: 75 Micrometer
• Outer Diameter: 75 Micrometer
• Outer Diameter: 75 Micrometer

Device Identifiers

Device Issuing Agency	Device ID
GS1	00879397000142 [Primary]

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-07-15

On-Brand Devices [Embozene Microspheres (Color-Advanced)]

• 00879397009121: Microspheres for Embolization
• 00879397009114: Microspheres for Embolization
• 00879397007127: Microspheres for Embolization
• 00879397007110: Microspheres for Embolization
• 00879397005123: Microspheres for Embolization
• 00879397005116: Microspheres for Embolization
• 00879397004126: Microspheres for Embolization
• 00879397004119: Microspheres for Embolization
• 00879397002122: Microspheres for Embolization
• 00879397002115: Microspheres for Embolization
• 00879397001125: Microspheres for Embolization
• 00879397001118: Microspheres for Embolization
• 00879397000142: Microspheres for Embolization
• 00879397000135: Microspheres for Embolization
• 00879397000128: Microspheres for Embolization
• 00879397000111: Microspheres for Embolization
• 00879397000104: Microspheres for Embolization
• 00879397000098: Microspheres for Embolization
• 00879397000081: Microspheres for Embolization
• 00879397000074: Microspheres for Embolization