NovoSorb BTM

Basic Information

• Brand Name: NovoSorb BTM
• Primary DI: 09349155000161
• Version / Model: BTM-2040
• Company Name: POLYNOVO BIOMATERIALS PTY LIMITED
• Labeler DUNS: 752326723
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-16
• Public Version: 2
• Public Version Date: 2023-03-30
• Public Version Status: Update
• Public Device Record Key: 74c7938e-41f6-4f4d-828c-e6af7a3128f3

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QSZ	Absorbable Synthetic Wound Dressing	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
64853	Synthetic wound matrix dressing	A sterile bioabsorbable device designed to be applied to hard-to-heal wounds (e.g., diabetic and venous insufficiency ulcers) or burns that involve the dermis, and that provides a matrix of structural synthetic fibres to facilitate the infiltration of native skin elements (e.g., fibroblasts, leukocytes, blood vessels) for skin regeneration; it may in addition be intended to facilitate regeneration of hard tissues such as bone (e.g., in cases of osteomyelitis) and may provide wound exudate absorbency. It does not contain biological materials. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09349155000161	GS1
Package	09349155000178	GS1	Box	5	In Commercial Distribution
Package	09349155000185	GS1	Case	25	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K172140	000

Device Sizes

Type	Value	Unit	Text
Length	20	Centimeter
Width	40	Centimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – 25 Degrees Celsius