Foundation DRS Solo

GUDID 00850047730053

Fenestrated

Bionova Medical Inc.

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• Primary Device ID: 00850047730053
• NIH Device Record Key: 24b5cf50-4d38-4f06-ae4a-af210367ffb9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Foundation DRS Solo
• Version Model Number: FS1-F-1012
• Company DUNS: 080325588
• Company Name: Bionova Medical 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 9017482581
• Email: info@bionovamedical.com
• Phone: 9017482581
• Email: info@bionovamedical.com
• Phone: 9017482581
• Email: info@bionovamedical.com
• Phone: 9017482581
• Email: info@bionovamedical.com
• Phone: 9017482581
• Email: info@bionovamedical.com
• Phone: 9017482581
• Email: info@bionovamedical.com
• Phone: 9017482581
• Email: info@bionovamedical.com
• Phone: 9017482581
• Email: info@bionovamedical.com
• Phone: 9017482581
• Email: info@bionovamedical.com
• Phone: 9017482581
• Email: info@bionovamedical.com
• Phone: 9017482581
• Email: info@bionovamedical.com
• Phone: 9017482581
• Email: info@bionovamedical.com
• Phone: 9017482581
• Email: info@bionovamedical.com
• Phone: 9017482581
• Email: info@bionovamedical.com
• Phone: 9017482581
• Email: info@bionovamedical.com
• Phone: 9017482581
• Email: info@bionovamedical.com
• Phone: 9017482581
• Email: info@bionovamedical.com
• Phone: 9017482581
• Email: info@bionovamedical.com
• Phone: 9017482581
• Email: info@bionovamedical.com
• Phone: 9017482581
• Email: info@bionovamedical.com
• Phone: 9017482581
• Email: info@bionovamedical.com
• Phone: 9017482581
• Email: info@bionovamedical.com
• Phone: 9017482581
• Email: info@bionovamedical.com
• Phone: 9017482581
• Email: info@bionovamedical.com
• Phone: 9017482581
• Email: info@bionovamedical.com
• Phone: 9017482581
• Email: info@bionovamedical.com
• Phone: 9017482581
• Email: info@bionovamedical.com
• Phone: 9017482581
• Email: info@bionovamedical.com
• Phone: 9017482581
• Email: info@bionovamedical.com
• Phone: 9017482581
• Email: info@bionovamedical.com
• Phone: 9017482581
• Email: info@bionovamedical.com
• Phone: 9017482581
• Email: info@bionovamedical.com
• Phone: 9017482581
• Email: info@bionovamedical.com

Device Dimensions

• Length: 10 Centimeter
• Width: 12.5 Centimeter
• Length: 10 Centimeter
• Width: 12.5 Centimeter
• Length: 10 Centimeter
• Width: 12.5 Centimeter
• Length: 10 Centimeter
• Width: 12.5 Centimeter
• Length: 10 Centimeter
• Width: 12.5 Centimeter
• Length: 10 Centimeter
• Width: 12.5 Centimeter
• Length: 10 Centimeter
• Width: 12.5 Centimeter
• Length: 10 Centimeter
• Width: 12.5 Centimeter
• Length: 10 Centimeter
• Width: 12.5 Centimeter
• Length: 10 Centimeter
• Width: 12.5 Centimeter
• Length: 10 Centimeter
• Width: 12.5 Centimeter
• Length: 10 Centimeter
• Width: 12.5 Centimeter
• Length: 10 Centimeter
• Width: 12.5 Centimeter
• Length: 10 Centimeter
• Width: 12.5 Centimeter
• Length: 10 Centimeter
• Width: 12.5 Centimeter
• Length: 10 Centimeter
• Width: 12.5 Centimeter
• Length: 10 Centimeter
• Width: 12.5 Centimeter
• Length: 10 Centimeter
• Width: 12.5 Centimeter
• Length: 10 Centimeter
• Width: 12.5 Centimeter
• Length: 10 Centimeter
• Width: 12.5 Centimeter
• Length: 10 Centimeter
• Width: 12.5 Centimeter
• Length: 10 Centimeter
• Width: 12.5 Centimeter
• Length: 10 Centimeter
• Width: 12.5 Centimeter
• Length: 10 Centimeter
• Width: 12.5 Centimeter
• Length: 10 Centimeter
• Width: 12.5 Centimeter
• Length: 10 Centimeter
• Width: 12.5 Centimeter
• Length: 10 Centimeter
• Width: 12.5 Centimeter
• Length: 10 Centimeter
• Width: 12.5 Centimeter
• Length: 10 Centimeter
• Width: 12.5 Centimeter
• Length: 10 Centimeter
• Width: 12.5 Centimeter
• Length: 10 Centimeter
• Width: 12.5 Centimeter
• Length: 10 Centimeter
• Width: 12.5 Centimeter
• Length: 10 Centimeter
• Width: 12.5 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850047730053 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210949

FDA Product Code

• FRO: Dressing, Wound, Drug
• FTM: Mesh, Surgical

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: 2023-07-13
• Device Publish Date: 2023-07-05

On-Brand Devices [Foundation DRS Solo]

• 00850047730077: Fenestrated
• 00850047730060: Fenestrated
• 00850047730053: Fenestrated
• 00850047730046: Fenestrated
• 00850047730039: FS1-2025
• 00850047730022: FS1-1025
• 00850047730015: FS1-1012
• 00850047730008: FS1-0505