Occlusin 500

GUDID 07540270000032

Occlusin 500 is a family of biodegradable, dense, hyperechoic microspheres, which are available in a range of calibrated sizes and marketed under the trade name Ekobi Embolization Microspheres. The microspheres consist of poly-DL-lactic-co-glycolic acid (PLGA) coated with bovine collagen. Following injection into the target vasculature, the collagen binds circulating platelets resulting in a platelet-rich clot which occludes the target vasculature. The microspheres slowly degrade and are removed from the body over 4-6 months.

IMBiotechnologies Ltd

Embolization particle, bioabsorbable Embolization particle, bioabsorbable Embolization particle, bioabsorbable Embolization particle, bioabsorbable Embolization particle, bioabsorbable Embolization particle, bioabsorbable Embolization particle, bioabsorbable Embolization particle, bioabsorbable Embolization particle, bioabsorbable Embolization particle, bioabsorbable

• Primary Device ID: 07540270000032
• NIH Device Record Key: a20f8b18-aa20-4ea9-83de-66d319c96eb4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Occlusin 500
• Version Model Number: Ekobi 503
• Company DUNS: 244234295
• Company Name: IMBiotechnologies Ltd
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-780-945-6609
• Email: contact@imbiotechnologies.com
• Phone: 1-780-945-6609
• Email: contact@imbiotechnologies.com
• Phone: 1-780-945-6609
• Email: contact@imbiotechnologies.com
• Phone: 1-780-945-6609
• Email: contact@imbiotechnologies.com
• Phone: 1-780-945-6609
• Email: contact@imbiotechnologies.com
• Phone: 1-780-945-6609
• Email: contact@imbiotechnologies.com
• Phone: 1-780-945-6609
• Email: contact@imbiotechnologies.com
• Phone: 1-780-945-6609
• Email: contact@imbiotechnologies.com
• Phone: 1-780-945-6609
• Email: contact@imbiotechnologies.com
• Phone: 1-780-945-6609
• Email: contact@imbiotechnologies.com

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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry location
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry location
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry location
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry location
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry location
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry location
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry location
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry location
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry location
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry location

Device Identifiers

Device Issuing Agency	Device ID
GS1	07540270000032 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093813

FDA Product Code

• KRD: Device, Vascular, For Promoting Embolization

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: 2019-05-30
• Device Publish Date: 2019-05-22

On-Brand Devices [Occlusin 500]

• 07540270000070: Occlusin 500 is a family of biodegradable dense microspheres which are available in a range of c
• 07540270000063: Occlusin 500 is a family of biodegradable dense microspheres which are available in a range of c
• 07540270000056: Occlusin 500 is a family of biodegradable dense microspheres which are available in a range of c
• 07540270000049: Occlusin 500 is a family of biodegradable dense microspheres which are available in a range of c
• 07540270000032: Occlusin 500 is a family of biodegradable, dense, hyperechoic microspheres, which are available
• 07540270000025: Occlusin 500 is a family of biodegradable, dense, hyperechoic microspheres, which are available
• 07540270000018: Occlusin 500 is a family of biodegradable, dense, hyperechoic microspheres, which are available