Suprathel® CW 210910-US, 250910-US

GUDID 04260184022281

Suprathel® CW is an absorbable, micro-porous membrane and alloplastic skin substitute for the treatment of wounds, including pressure and venous ulcers, venous stasis and diabetic ulcers, ulcers caused by mixed vascular etiologies.

Polymedics Innovations GmbH

Synthetic wound matrix dressing

• Primary Device ID: 04260184022281
• NIH Device Record Key: 133edf02-0bef-4158-9bec-c72bceb906cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Suprathel® CW
• Version Model Number: Suprathel CW 9x10
• Catalog Number: 210910-US, 250910-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	04260184022236 [Primary]
GS1	04260184022281 [Package]; Contains: 04260184022236; Package: Carton envelope [1 Units]; In Commercial Distribution
GS1	04260184022298 [Package]; Contains: 04260184022236; Package: Carton envelope [5 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® CW]

• 04260184022571: Suprathel® CW is an absorbable, micro-porous membrane and alloplastic skin substitute for the t
• 04260184022281: Suprathel® CW is an absorbable, micro-porous membrane and alloplastic skin substitute for the t
• 04260184022175: Suprathel® CW is an absorbable, micro-porous membrane and alloplastic skin substitute for the t