NovoSorb BTM

GUDID 09349155002219

NovoSorb® BTM is a biodegradable polyurethane porous matrix adhered to a transparent sealing membrane. The sealing membrane is designed to physiologically close the wound limiting evaporative moisture loss during integration of the matrix. NovoSorb® BTM is supplied in various sizes, ranging from 4cm2 to 800cm2. NovoSorb® BTM is a fenestrated single use, terminally sterilized device, individually packed in a transparent polymer pouch enclosed in an aluminized pouch contained in a cardboard envelope.

POLYNOVO BIOMATERIALS PTY LIMITED

Synthetic wound matrix dressing

• Primary Device ID: 09349155002219
• NIH Device Record Key: ba8ef0e9-df52-4436-a773-359eaf68efb7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NovoSorb BTM
• Version Model Number: BTM-0505
• 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

Device Dimensions

• Length: 5 Centimeter
• Width: 5 Centimeter
• Length: 5 Centimeter
• Width: 5 Centimeter
• Length: 5 Centimeter
• Width: 5 Centimeter
• Length: 5 Centimeter
• Width: 5 Centimeter
• Length: 5 Centimeter
• Width: 5 Centimeter
• Length: 5 Centimeter
• Width: 5 Centimeter
• Length: 5 Centimeter
• Width: 5 Centimeter
• Length: 5 Centimeter
• Width: 5 Centimeter
• Length: 5 Centimeter
• Width: 5 Centimeter
• Length: 5 Centimeter
• Width: 5 Centimeter
• Length: 5 Centimeter
• Width: 5 Centimeter
• Length: 5 Centimeter
• Width: 5 Centimeter
• Length: 5 Centimeter
• Width: 5 Centimeter
• Length: 5 Centimeter
• Width: 5 Centimeter
• Length: 5 Centimeter
• Width: 5 Centimeter
• Length: 5 Centimeter
• Width: 5 Centimeter
• Length: 5 Centimeter
• Width: 5 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	09349155002219 [Primary]
GS1	09349155002226 [Package]; Package: Box [5 Units]; In Commercial Distribution
GS1	09349155002233 [Package]; Contains: 09349155002226; Package: Case [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172140

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: 2023-06-23
• Device Publish Date: 2023-06-15

On-Brand Devices [NovoSorb BTM]

• 09349155000161: NovoSorb® BTM is a biodegradable polyurethane porous matrix adhered to a transparent sealing me
• 09349155000130: NovoSorb® BTM is a biodegradable polyurethane porous matrix adhered to a transparent sealing me
• 09349155000109: NovoSorb® BTM is a biodegradable polyurethane porous matrix adhered to a transparent sealing me
• 09349155002219: NovoSorb® BTM is a biodegradable polyurethane porous matrix adhered to a transparent sealing me