FDA.reportPublic FDA data

NovoSorb MTX

Primary DI
09349155001342
Brand
NovoSorb MTX
Company
POLYNOVO BIOMATERIALS PTY LIMITED
Model
MTX-2040
Device description
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.
Published
2023-09-27
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
QSZAbsorbable Synthetic Wound Dressing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QSZAbsorbable Synthetic Wound DressingUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221686000
K242149000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221686000NovoSorb MatrixPolynovo Biomaterials Pty, Ltd.2022-09-15QSZ
K242149000NovoSorb® MTXPolynovo Biomaterials Pty, Ltd.2025-03-05QSZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09349155001359PackageGS15In Commercial Distribution
09349155001366PackageGS125In Commercial Distribution
09349155001342PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09349155001359093491550013599349155001359
09349155001366093491550013669349155001366
09349155001342093491550013429349155001342

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
Height2Millimeter
Length40Centimeter
Width20Centimeter

Storage And Handling#

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

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
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
09349155000109NovoSorb BTMBTM-10102022-11-16
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06977727072617Redermo Wound MatrixBeijing Kreate Medical Co., Ltd.QSZ2026-04-30
06977727072624Redermo Wound MatrixBeijing Kreate Medical Co., Ltd.QSZ2026-04-30
06977727072631Redermo Wound MatrixBeijing Kreate Medical Co., Ltd.QSZ2026-04-30
06977727072648Redermo Wound MatrixBeijing Kreate Medical Co., Ltd.QSZ2026-04-30
06977727072815SurCura Wound MatrixBeijing Kreate Medical Co., Ltd.QSZ2026-04-30
06977727072822SurCura Wound MatrixBeijing Kreate Medical Co., Ltd.QSZ2026-04-30
06977727072839SurCura Wound MatrixBeijing Kreate Medical Co., Ltd.QSZ2026-04-30
06977727072846SurCura Wound MatrixBeijing Kreate Medical Co., Ltd.QSZ2026-04-30
00854258006389Restrata(R)Acera Surgical IncQSZ2026-04-15
00854258006396Restrata MeshedAcera Surgical IncQSZ2026-04-15
00850021883072SiOxD® ORSioxmed, LLCQSZ2026-03-17
00812005030537Mirragen Advanced Wound MatrixETS Wound Care LLCQSZ2026-03-03
00817337000616HyalomatrixAnika Therapeutics, Inc.QSZ2026-02-22
00850021883003SiOxD Wound MatrixSioxmed, LLCQSZ2025-11-10
00850021883041SiOxD Wound MatrixSioxmed, LLCQSZ2025-11-10
00850047730305Foundation DRS SoloBionova Medical Inc.QSZ2025-09-17
00850047730312Foundation DRS SoloBionova Medical Inc.QSZ2025-09-17
00850047730329Foundation DRS SoloBionova Medical Inc.QSZ2025-09-17
00850047730336Foundation DRS SoloBionova Medical Inc.QSZ2025-09-17
00850047730343Foundation DRS SoloBionova Medical Inc.QSZ2025-09-17
00852513007393Phoenix Surgical Wound Matrix FenestratedNANOFIBER SOLUTIONS, INC.QSZ2025-04-17
00852513007409Phoenix Surgical Wound Matrix FenestratedNANOFIBER SOLUTIONS, INC.QSZ2025-04-17
00852513007416Phoenix Surgical Wound Matrix FenestratedNANOFIBER SOLUTIONS, INC.QSZ2025-04-17
00852513007423Phoenix Surgical Wound Matrix FenestratedNANOFIBER SOLUTIONS, INC.QSZ2025-04-17
00852513007430Phoenix Surgical Wound Matrix FenestratedNANOFIBER SOLUTIONS, INC.QSZ2025-04-17
10850021883000SiOxD Wound MatrixSioxmed, LLCQSZ2025-02-17
00852513007362ElectroFiber 3D MatrixNANOFIBER SOLUTIONS, INC.QSZ2024-11-14
00852513007379ElectroFiber 3D MatrixNANOFIBER SOLUTIONS, INC.QSZ2024-11-14
00852513007386ElectroFiber 3D MatrixNANOFIBER SOLUTIONS, INC.QSZ2024-11-14
04260184021598Suprathel®Polymedics Innovations GmbHQSZ2024-10-11