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

• 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