Sentrex BioSponge Ultra

GUDID 00850047730299

Bionova Medical Inc.

Cavity-wound management dressing, non-antimicrobial

• Primary Device ID: 00850047730299
• NIH Device Record Key: f6b6d82e-f033-4bc1-bc40-784dece7eb27
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sentrex BioSponge Ultra
• Version Model Number: 500-1020
• 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: 901-748-2581
• Email: info@bionovamedical.com
• Phone: 901-748-2581
• Email: info@bionovamedical.com
• Phone: 901-748-2581
• Email: info@bionovamedical.com
• Phone: 901-748-2581
• Email: info@bionovamedical.com
• Phone: 901-748-2581
• Email: info@bionovamedical.com
• Phone: 901-748-2581
• Email: info@bionovamedical.com
• Phone: 901-748-2581
• Email: info@bionovamedical.com
• Phone: 901-748-2581
• Email: info@bionovamedical.com
• Phone: 901-748-2581
• Email: info@bionovamedical.com
• Phone: 901-748-2581
• Email: info@bionovamedical.com
• Phone: 901-748-2581
• Email: info@bionovamedical.com
• Phone: 901-748-2581
• Email: info@bionovamedical.com
• Phone: 901-748-2581
• Email: info@bionovamedical.com
• Phone: 901-748-2581
• Email: info@bionovamedical.com
• Phone: 901-748-2581
• Email: info@bionovamedical.com
• Phone: 901-748-2581
• Email: info@bionovamedical.com
• Phone: 901-748-2581
• Email: info@bionovamedical.com

Device Dimensions

• Length: 10 Centimeter
• Width: 20 Centimeter
• Length: 10 Centimeter
• Width: 20 Centimeter
• Length: 10 Centimeter
• Width: 20 Centimeter
• Length: 10 Centimeter
• Width: 20 Centimeter
• Length: 10 Centimeter
• Width: 20 Centimeter
• Length: 10 Centimeter
• Width: 20 Centimeter
• Length: 10 Centimeter
• Width: 20 Centimeter
• Length: 10 Centimeter
• Width: 20 Centimeter
• Length: 10 Centimeter
• Width: 20 Centimeter
• Length: 10 Centimeter
• Width: 20 Centimeter
• Length: 10 Centimeter
• Width: 20 Centimeter
• Length: 10 Centimeter
• Width: 20 Centimeter
• Length: 10 Centimeter
• Width: 20 Centimeter
• Length: 10 Centimeter
• Width: 20 Centimeter
• Length: 10 Centimeter
• Width: 20 Centimeter
• Length: 10 Centimeter
• Width: 20 Centimeter
• Length: 10 Centimeter
• Width: 20 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850047730299 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123961

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 [Sentrex BioSponge Ultra]

• 00850047730299: 500-1020
• 00850047730282: 500-1010
• 00850047730275: 500-0505