FDA.reportPublic FDA data

NovoSorb BTM

Primary DI
09349155000109
Brand
NovoSorb BTM
Company
POLYNOVO BIOMATERIALS PTY LIMITED
Model
BTM-1010
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.
Published
2022-11-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug
QSZAbsorbable Synthetic Wound Dressing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU
QSZAbsorbable Synthetic Wound DressingUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172140000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172140000NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10cm), NovoSorb BTM Wound Dressing (10cm x 20cm), NovoSorb BTM Wound Dressing (20cm x 40cm)Polynovo Biomaterials Pty, Ltd.2017-08-11QSZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09349155000116PackageGS15In Commercial Distribution
09349155000123PackageGS125In Commercial Distribution
09349155000109PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09349155000116093491550001169349155000116
09349155000123093491550001239349155000123
09349155000109093491550001099349155000109

GMDN Terms#

Term, Definition table
TermDefinition
Synthetic wound matrix dressingA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length10Centimeter
Width10Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1-760-448-5515info@polynovo.com

Regulatory Flags#

DUNS number
752326723
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09349155001281NovoSorb MTXMTX-10102023-04-04
09349155001311NovoSorb MTXMTX-10202023-04-04
09349155001342NovoSorb MTXMTX-20402023-09-27
09349155002608NovoSorb MTXMTX-05052024-06-17
09349155001359NovoSorb MTXMTX-20402023-09-27
09349155002219NovoSorb BTMBTM-05052023-06-15
09349155001298NovoSorb MTXMTX-10102023-04-04
09349155001328NovoSorb MTXMTX-10202023-04-04
09349155000130NovoSorb BTMBTM-10202022-11-16
09349155000161NovoSorb BTMBTM-20402022-11-16
09349155000239NovoSorb SynPathSYN-10102022-11-16
09349155001137NovoSorb SynPathSYN-03042022-11-16
09349155001168NovoSorb SynPathSYN-05052022-11-16
09349155001199NovoSorb SynPathSYN-02032022-11-16
09349155001229NovoSorb SynPathSYN-02022022-11-16

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Primary DI, Brand, Company table
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