SupraSDRM® 310101-US

GUDID 04260184023011

SupraSDRM® is an absorbable, microporous biodegradable matrix indicated for the management of superficial dermal wounds, split-skin graft donor sites, pressure and venous ulcers, and 2nd degree burns. The biodegradable matrix is designed for trauma and surgical wounds involving soft tissues. The SupraSDRM matrix is available in various sizes for use in covering and protecting superficial and partial thickness soft tissue wounds.

Polymedics Innovations GmbH

Synthetic wound matrix dressing

• Primary Device ID: 04260184023011
• NIH Device Record Key: 6d9ae906-e822-4049-9840-57d7877b21a2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SupraSDRM®
• Version Model Number: SupraSDRM 1x1
• Catalog Number: 310101-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
• 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 25 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260184023004 [Primary]
GS1	04260184023011 [Package]; Contains: 04260184023004; Package: Carton box [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170213

FDA Product Code

• FRO: Dressing, Wound, Drug
• 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: 2021-09-20
• Device Publish Date: 2021-09-10

On-Brand Devices [SupraSDRM®]

• 04260184023011: SupraSDRM® is an absorbable, microporous biodegradable matrix indicated for the management of s
• 04260184023424: SupraSDRM® is an absorbable, microporous biodegradable matrix indicated for the management of s
• 04260184023325: SupraSDRM® is an absorbable, microporous biodegradable matrix indicated for the management of s
• 04260184023226: SupraSDRM® is an absorbable, microporous biodegradable matrix indicated for the management of s
• 04260184023158: SupraSDRM® is an absorbable, microporous biodegradable matrix indicated for the management of s
• 04260184023134: SupraSDRM® is an absorbable, microporous biodegradable matrix indicated for the management of s
• 04260184023110: SupraSDRM® is an absorbable, microporous biodegradable matrix indicated for the management of s
• 04260184023097: SupraSDRM® is an absorbable, microporous biodegradable matrix indicated for the management of s
• 04260184023073: SupraSDRM® is an absorbable, microporous biodegradable matrix indicated for the management of s
• 04260184023035: SupraSDRM® is an absorbable, microporous biodegradable matrix indicated for the management of s