Surgaflex

GUDID 00850019162288

Surgaflex™ is a sterile, single use absorbent polymeric wound matrix composed primarily of polyvinyl alcohol with a polymeric surface coating containing ionic and metallic silver. It has very low amounts of silver, with a maximum of 0.16 mg/sq in. Surgaflex™ is intended for the management of wounds. The device is packaged in sterile, sealed boxes of 5.

IMBED BIOSCIENCES, INC.

Exudate-absorbent first aid dressing, hydrophilic-gel, antimicrobial

• Primary Device ID: 00850019162288
• NIH Device Record Key: a5aafbfb-4957-4ba8-b1b2-5493e60cdc2c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Surgaflex
• Version Model Number: 91017
• Company DUNS: 962084500
• Company Name: IMBED BIOSCIENCES, 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: 888-472-9898
• Email: cs@imbedbio.com
• Phone: 888-472-9898
• Email: cs@imbedbio.com
• Phone: 888-472-9898
• Email: cs@imbedbio.com
• Phone: 888-472-9898
• Email: cs@imbedbio.com
• Phone: 888-472-9898
• Email: cs@imbedbio.com
• Phone: 888-472-9898
• Email: cs@imbedbio.com
• Phone: 888-472-9898
• Email: cs@imbedbio.com
• Phone: 888-472-9898
• Email: cs@imbedbio.com
• Phone: 888-472-9898
• Email: cs@imbedbio.com
• Phone: 888-472-9898
• Email: cs@imbedbio.com
• Phone: 888-472-9898
• Email: cs@imbedbio.com
• Phone: 888-472-9898
• Email: cs@imbedbio.com
• Phone: 888-472-9898
• Email: cs@imbedbio.com
• Phone: 888-472-9898
• Email: cs@imbedbio.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850019162288 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153756

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: 2025-03-04
• Device Publish Date: 2025-02-24

On-Brand Devices [Surgaflex]

• 00850019162318: Surgaflex, 4cm x 20cm, Individually packaged
• 00850019162301: Surgaflex, 4cm x 6cm, Individually Packaged
• 00850019162295: Surgaflex™ is a sterile, single use absorbent polymeric wound matrix composed primarily of pol
• 00850019162288: Surgaflex™ is a sterile, single use absorbent polymeric wound matrix composed primarily of pol