NovoSorb MTX

GUDID 09349155001328

NovoSorb® MTX is a biodegradable polyurethane porous matrix supplied in various sizes, ranging from 4cm2 to 800cm2. NovoSorb® MTX is a single use, terminally sterilized device, individually packed in a transparent polymer pouch enclosed in an aluminized pouch contained in a cardboard envelope. NovoSorb® MTX can be used where a delay in normal wound healing is not considered necessary by the treating physician, e.g., definitive wound closure by secondary intention.

POLYNOVO BIOMATERIALS PTY LIMITED

Synthetic wound matrix dressing

• Primary Device ID: 09349155001328
• NIH Device Record Key: e7e33f93-3f00-4602-83d3-dc81b6fc7c10
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NovoSorb MTX
• Version Model Number: MTX-1020
• 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@polynovo.com
• Phone: +1-760-448-5515
• Email: info@polynovo.com
• Phone: +1-760-448-5515
• Email: info@polynovo.com
• Phone: +1-760-448-5515
• Email: info@polynovo.com
• Phone: +1-760-448-5515
• Email: info@polynovo.com
• Phone: +1-760-448-5515
• Email: info@polynovo.com
• Phone: +1-760-448-5515
• Email: info@polynovo.com
• Phone: +1-760-448-5515
• Email: info@polynovo.com
• Phone: +1-760-448-5515
• Email: info@polynovo.com
• Phone: +1-760-448-5515
• Email: info@polynovo.com
• Phone: +1-760-448-5515
• Email: info@polynovo.com
• Phone: +1-760-448-5515
• Email: info@polynovo.com
• Phone: +1-760-448-5515
• Email: info@polynovo.com
• Phone: +1-760-448-5515
• Email: info@polynovo.com
• Phone: +1-760-448-5515
• Email: info@polynovo.com
• Phone: +1-760-448-5515
• Email: info@polynovo.com
• Phone: +1-760-448-5515
• Email: info@polynovo.com
• Phone: +1-760-448-5515
• Email: info@polynovo.com

Device Dimensions

• Length: 20 Centimeter
• Width: 10 Centimeter
• Length: 20 Centimeter
• Width: 10 Centimeter
• Length: 20 Centimeter
• Width: 10 Centimeter
• Length: 20 Centimeter
• Width: 10 Centimeter
• Length: 20 Centimeter
• Width: 10 Centimeter
• Length: 20 Centimeter
• Width: 10 Centimeter
• Length: 20 Centimeter
• Width: 10 Centimeter
• Length: 20 Centimeter
• Width: 10 Centimeter
• Length: 20 Centimeter
• Width: 10 Centimeter
• Length: 20 Centimeter
• Width: 10 Centimeter
• Length: 20 Centimeter
• Width: 10 Centimeter
• Length: 20 Centimeter
• Width: 10 Centimeter
• Length: 20 Centimeter
• Width: 10 Centimeter
• Length: 20 Centimeter
• Width: 10 Centimeter
• Length: 20 Centimeter
• Width: 10 Centimeter
• Length: 20 Centimeter
• Width: 10 Centimeter
• Length: 20 Centimeter
• Width: 10 Centimeter
• Length: 20 Centimeter
• Width: 10 Centimeter

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	09349155001311 [Primary]
GS1	09349155001328 [Package]; Contains: 09349155001311; Package: Box [5 Units]; In Commercial Distribution
GS1	09349155001335 [Package]; Package: Case [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221686

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: 2023-04-12
• Device Publish Date: 2023-04-04

On-Brand Devices [NovoSorb MTX]

• 09349155001328: NovoSorb® MTX is a biodegradable polyurethane porous matrix supplied in various sizes, ranging
• 09349155001298: NovoSorb® MTX is a biodegradable polyurethane porous matrix supplied in various sizes, ranging
• 09349155001359: NovoSorb® MTX is a biodegradable polyurethane porous matrix supplied in various sizes, ranging
• 09349155002608: NovoSorb® MTX is a biodegradable polyurethane porous matrix supplied in various sizes, ranging