Banner Balloon Guide Catheter INC-12098

GUDID 08600092100040

Banner Balloon Guide Catheter

Eosolutions, Corp.

Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided

• Primary Device ID: 08600092100040
• NIH Device Record Key: a3969645-ad21-4efe-ada0-745b13ac5199
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Banner Balloon Guide Catheter
• Version Model Number: INC-12098
• Catalog Number: INC-12098
• Company DUNS: 118834560
• Company Name: Eosolutions, Corp.
• 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: 9547035271
• Email: Marianne@eosolutionscorp.com
• Phone: 9547035271
• Email: Marianne@eosolutionscorp.com
• Phone: 9547035271
• Email: Marianne@eosolutionscorp.com
• Phone: 9547035271
• Email: Marianne@eosolutionscorp.com
• Phone: 9547035271
• Email: Marianne@eosolutionscorp.com
• Phone: 9547035271
• Email: Marianne@eosolutionscorp.com
• Phone: 9547035271
• Email: Marianne@eosolutionscorp.com
• Phone: 9547035271
• Email: Marianne@eosolutionscorp.com
• Phone: 9547035271
• Email: Marianne@eosolutionscorp.com
• Phone: 9547035271
• Email: Marianne@eosolutionscorp.com
• Phone: 9547035271
• Email: Marianne@eosolutionscorp.com
• Phone: 9547035271
• Email: Marianne@eosolutionscorp.com
• Phone: 9547035271
• Email: Marianne@eosolutionscorp.com
• Phone: 9547035271
• Email: Marianne@eosolutionscorp.com
• Phone: 9547035271
• Email: Marianne@eosolutionscorp.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08600092100040 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220331

FDA Product Code

• QJP: Catheter, Percutaneous, Neurovasculature

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: 2023-12-04
• Device Publish Date: 2023-01-10