NovoSorb SynPath

GUDID 09349155000239

NovoSorb® SynPath™ is a synthetic, acellular, dermal matrix made from the proprietary NovoSorb® technology that supports the adherence and proliferation of the vital cells involved in new tissue regeneration. NovoSorb® SynPath™ is a non-toxic, porous network of biodegradable synthetic polymers that act as a support template for cellular repair. The matrix is fenestrated to allow excess exudate from the wound to pass through to a secondary absorbent layer to prevent maceration. As the matrix integrates into the wound bed, it supports the creation of a neodermal structure.

POLYNOVO BIOMATERIALS PTY LIMITED

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• Primary Device ID: 09349155000239
• NIH Device Record Key: 0d61edd8-ff9e-4c08-90c9-358dbbed7178
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NovoSorb SynPath
• Version Model Number: SYN-1010
• Company DUNS: 752326723
• Company Name: POLYNOVO BIOMATERIALS PTY LIMITED
• 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: +1-760-448-5515
• Email: info.US@polynovo.com
• Phone: +1-760-448-5515
• Email: info.US@polynovo.com
• Phone: +1-760-448-5515
• Email: info.US@polynovo.com
• Phone: +1-760-448-5515
• Email: info.US@polynovo.com
• Phone: +1-760-448-5515
• Email: info.US@polynovo.com
• Phone: +1-760-448-5515
• Email: info.US@polynovo.com
• Phone: +1-760-448-5515
• Email: info.US@polynovo.com
• Phone: +1-760-448-5515
• Email: info.US@polynovo.com
• Phone: +1-760-448-5515
• Email: info.US@polynovo.com
• Phone: +1-760-448-5515
• Email: info.US@polynovo.com
• Phone: +1-760-448-5515
• Email: info.US@polynovo.com
• Phone: +1-760-448-5515
• Email: info.US@polynovo.com
• Phone: +1-760-448-5515
• Email: info.US@polynovo.com
• Phone: +1-760-448-5515
• Email: info.US@polynovo.com
• Phone: +1-760-448-5515
• Email: info.US@polynovo.com
• Phone: +1-760-448-5515
• Email: info.US@polynovo.com
• Phone: +1-760-448-5515
• Email: info.US@polynovo.com
• Phone: +1-760-448-5515
• Email: info.US@polynovo.com
• Phone: +1-760-448-5515
• Email: info.US@polynovo.com
• Phone: +1-760-448-5515
• Email: info.US@polynovo.com
• Phone: +1-760-448-5515
• Email: info.US@polynovo.com
• Phone: +1-760-448-5515
• Email: info.US@polynovo.com
• Phone: +1-760-448-5515
• Email: info.US@polynovo.com
• Phone: +1-760-448-5515
• Email: info.US@polynovo.com
• Phone: +1-760-448-5515
• Email: info.US@polynovo.com
• Phone: +1-760-448-5515
• Email: info.US@polynovo.com
• Phone: +1-760-448-5515
• Email: info.US@polynovo.com
• Phone: +1-760-448-5515
• Email: info.US@polynovo.com
• Phone: +1-760-448-5515
• Email: info.US@polynovo.com
• Phone: +1-760-448-5515
• Email: info.US@polynovo.com
• Phone: +1-760-448-5515
• Email: info.US@polynovo.com
• Phone: +1-760-448-5515
• Email: info.US@polynovo.com
• Phone: +1-760-448-5515
• Email: info.US@polynovo.com

Device Dimensions

• Length: 10 Centimeter
• Width: 10 Centimeter
• Length: 10 Centimeter
• Width: 10 Centimeter
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Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	09349155000239 [Primary]
GS1	09349155000246 [Package]; Package: Box [5 Units]; In Commercial Distribution
GS1	09349155000253 [Package]; Contains: 09349155000246; Package: Case [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172140

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: 2022-11-24
• Device Publish Date: 2022-11-16

On-Brand Devices [NovoSorb SynPath]

• 09349155001229: NovoSorb® SynPath™ is a synthetic, acellular, dermal matrix made from the proprietary NovoSor
• 09349155001199: NovoSorb® SynPath™ is a synthetic, acellular, dermal matrix made from the proprietary NovoSor
• 09349155001168: NovoSorb® SynPath™ is a synthetic, acellular, dermal matrix made from the proprietary NovoSor
• 09349155001137: NovoSorb® SynPath™ is a synthetic, acellular, dermal matrix made from the proprietary NovoSor
• 09349155000239: NovoSorb® SynPath™ is a synthetic, acellular, dermal matrix made from the proprietary NovoSor