Suprathel® 11F001-US

GUDID 04260184021604

Suprathel® is an absorbable, microporous membrane and alloplastic skin substitute for the treatment of wounds, split-skin donor sites, and burns as indicated hereinafter. The device is supplied sterile in a variety of sizes to be trimmed by the surgeon to meet the individual patient’s needs.

Polymedics Innovations GmbH

Synthetic wound matrix dressing

• Primary Device ID: 04260184021604
• NIH Device Record Key: 1dc49c0a-8725-4161-bebf-9e0c5543a040
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Suprathel®
• Version Model Number: Suprathel Face Mask
• Catalog Number: 11F001-US
• Company DUNS: 344089540
• Company Name: Polymedics Innovations GmbH
• 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: +1 646-604-2771
• Email: info.usa@polymedics.com
• Phone: +1 646-604-2771
• Email: info.usa@polymedics.com
• Phone: +1 646-604-2771
• Email: info.usa@polymedics.com
• Phone: +1 646-604-2771
• Email: info.usa@polymedics.com
• Phone: +1 646-604-2771
• Email: info.usa@polymedics.com
• Phone: +1 646-604-2771
• Email: info.usa@polymedics.com
• Phone: +1 646-604-2771
• Email: info.usa@polymedics.com
• Phone: +1 646-604-2771
• Email: info.usa@polymedics.com
• Phone: +1 646-604-2771
• Email: info.usa@polymedics.com
• Phone: +1 646-604-2771
• Email: info.usa@polymedics.com
• Phone: +1 646-604-2771
• Email: info.usa@polymedics.com
• Phone: +1 646-604-2771
• Email: info.usa@polymedics.com
• Phone: +1 646-604-2771
• Email: info.usa@polymedics.com
• Phone: +1 646-604-2771
• Email: info.usa@polymedics.com
• Phone: +1 646-604-2771
• Email: info.usa@polymedics.com
• Phone: +1 646-604-2771
• Email: info.usa@polymedics.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 22 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260184021598 [Primary]
GS1	04260184021604 [Package]; Contains: 04260184021598; Package: Carton envelope [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090160

FDA Product Code

• QSZ: Absorbable Synthetic Wound Dressing

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: 2024-10-21
• Device Publish Date: 2024-10-11

On-Brand Devices [Suprathel®]

• 04260184021130: Suprathel® is an absorbable, microporous membrane and alloplastic skin substitute for the treat
• 04260184021567: Suprathel® is an absorbable, microporous membrane and alloplastic skin substitute for the treat
• 04260184021475: Suprathel® is an absorbable, microporous membrane and alloplastic skin substitute for the treat
• 04260184021376: Suprathel® is an absorbable, microporous membrane and alloplastic skin substitute for the treat
• 04260184021277: Suprathel® is an absorbable, microporous membrane and alloplastic skin substitute for the treat
• 04260184021604: Suprathel® is an absorbable, microporous membrane and alloplastic skin substitute for the treat