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 Synthetic wound matrix dressing Synthetic wound matrix dressing Synthetic wound matrix dressing Synthetic wound matrix dressing Synthetic wound matrix dressing Synthetic wound matrix dressing Synthetic wound matrix dressing Synthetic wound matrix dressing Synthetic wound matrix dressing Synthetic wound matrix dressing Synthetic wound matrix dressing Synthetic wound matrix dressing Synthetic wound matrix dressing Synthetic wound matrix dressing Synthetic wound matrix dressing 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