Foundation DRS+ Duo

GUDID 00850047730145

Bionova Medical Inc.

Wound regenerating polysaccharide agent

• Primary Device ID: 00850047730145
• NIH Device Record Key: a471a15d-88d9-489f-aa55-01dc1381541b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Foundation DRS+ Duo
• Version Model Number: 802-2025
• 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

Device Dimensions

• Length: 20 Centimeter
• Width: 25 Centimeter
• Length: 20 Centimeter
• Width: 25 Centimeter
• Length: 20 Centimeter
• Width: 25 Centimeter
• Length: 20 Centimeter
• Width: 25 Centimeter
• Length: 20 Centimeter
• Width: 25 Centimeter
• Length: 20 Centimeter
• Width: 25 Centimeter
• Length: 20 Centimeter
• Width: 25 Centimeter
• Length: 20 Centimeter
• Width: 25 Centimeter
• Length: 20 Centimeter
• Width: 25 Centimeter
• Length: 20 Centimeter
• Width: 25 Centimeter
• Length: 20 Centimeter
• Width: 25 Centimeter
• Length: 20 Centimeter
• Width: 25 Centimeter
• Length: 20 Centimeter
• Width: 25 Centimeter
• Length: 20 Centimeter
• Width: 25 Centimeter
• Length: 20 Centimeter
• Width: 25 Centimeter
• Length: 20 Centimeter
• Width: 25 Centimeter
• Length: 20 Centimeter
• Width: 25 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850047730145 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240298

FDA Product Code

• FRO: Dressing, Wound, Drug

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: 2024-09-03
• Device Publish Date: 2024-08-26

On-Brand Devices [Foundation DRS+ Duo]

• 00850047730183: Perforated
• 00850047730176: Perforated
• 00850047730169: Perforated
• 00850047730152: Perforated
• 00850047730145: 802-2025
• 00850047730138: 802-1025
• 00850047730121: 802-1012
• 00850047730114: 802-0505