Embozene Microspheres (Opaque)

GUDID 00879397003280

Microspheres for Embolization

CELONOVA BIOSCIENCES, INC.

Embolization particle, non-bioabsorbable

• Primary Device ID: 00879397003280
• NIH Device Record Key: 96d67c5f-6597-434a-9501-8a23ea46d7b4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Embozene Microspheres (Opaque)
• Version Model Number: 12010-S0
• 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: 250 Micrometer
• Outer Diameter: 250 Micrometer
• Outer Diameter: 250 Micrometer
• Outer Diameter: 250 Micrometer
• Outer Diameter: 250 Micrometer
• Outer Diameter: 250 Micrometer
• Outer Diameter: 250 Micrometer
• Outer Diameter: 250 Micrometer
• Outer Diameter: 250 Micrometer
• Outer Diameter: 250 Micrometer

Device Identifiers

Device Issuing Agency	Device ID
GS1	00879397003280 [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 (Opaque)]

• 00879397003419: Microspheres for Embolization
• 00879397003402: Microspheres for Embolization
• 00879397003396: Microspheres for Embolization
• 00879397003389: Microspheres for Embolization
• 00879397003372: Microspheres for Embolization
• 00879397003365: Microspheres for Embolization
• 00879397003358: Microspheres for Embolization
• 00879397003341: Microspheres for Embolization
• 00879397003334: Microspheres for Embolization
• 00879397003327: Microspheres for Embolization
• 00879397003310: Microspheres for Embolization
• 00879397003303: Microspheres for Embolization
• 00879397003297: Microspheres for Embolization
• 00879397003280: Microspheres for Embolization
• 00879397003273: Microspheres for Embolization
• 00879397003266: Microspheres for Embolization
• 00879397003259: Microspheres for Embolization
• 00879397003242: Microspheres for Embolization
• 00879397003235: Microspheres for Embolization
• 00879397003228: Microspheres for Embolization