FDA.reportPublic FDA data

NovoSorb SynPath

Primary DI
09349155000239
Brand
NovoSorb SynPath
Company
POLYNOVO BIOMATERIALS PTY LIMITED
Model
SYN-1010
Device description
NovoSorb® SynPath™ is a synthetic, acellular, dermal matrix made from the proprietary NovoSorb® technology that supports the adherence and proliferation of the vital cells involved in new tissue regeneration. NovoSorb® SynPath™ is a non-toxic, porous network of biodegradable synthetic polymers that act as a support template for cellular repair. The matrix is fenestrated to allow excess exudate from the wound to pass through to a secondary absorbent layer to prevent maceration. As the matrix integrates into the wound bed, it supports the creation of a neodermal structure.
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
09349155000246PackageGS15In Commercial Distribution
09349155000253PackageGS125In Commercial Distribution
09349155000239PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09349155000246093491550002469349155000246
09349155000253093491550002539349155000253
09349155000239093491550002399349155000239

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.US@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
09349155002219NovoSorb BTMBTM-05052023-06-15
09349155000109NovoSorb BTMBTM-10102022-11-16
09349155000130NovoSorb BTMBTM-10202022-11-16
09349155000161NovoSorb BTMBTM-20402022-11-16
09349155003865NovoSorb SynPathSYN-B-02022026-06-25
09349155003988NovoSorb SynPathSYN-B-03032026-06-25
09349155004169NovoSorb SynPathSYN-B-05052026-06-25
09349155004404NovoSorb SynPathSYN-B-22RD2026-06-25
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
09349155001298NovoSorb MTXMTX-10102023-04-04
09349155001328NovoSorb MTXMTX-10202023-04-04
09349155001137NovoSorb SynPathSYN-03042022-11-16
09349155001168NovoSorb SynPathSYN-05052022-11-16
09349155001199NovoSorb SynPathSYN-02032022-11-16
09349155001229NovoSorb SynPathSYN-02022022-11-16

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04046961025153Prontosan®B. BRAUN MEDICAL INC.FRO2026-08-09
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00050428034880CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-08-08
10197344169429MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-08-07
10197344169436MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-08-07
00818582013796Puracyn® Plus Professional FormulaInnovacyn, Inc.FRO2026-07-31
00818582013802Puracyn® Plus Professional FormulaInnovacyn, Inc.FRO2026-07-31
10197344169405MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-31
00852421007683Pure&CleanPure & Clean, LLCFRO2026-07-29
00852421007850Pure&CleanPure & Clean, LLCFRO2026-07-29
04260056880667XPERIENCE Advanced Surgical IrrigationOSARTIS GmbHFRO2026-07-28
10841495149815QUIKCLOTTELEFLEX INCORPORATEDFRO2026-07-27
B665AC510011AC5 Advanced Wound SystemArch Therapeutics, Inc.FRO2026-07-24
B665AVX030011VIA LinxArch Therapeutics, Inc.FRO2026-07-24
00852421007300Pure&CleanPure & Clean, LLCFRO2026-07-22
00818582012867Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
00818582012881Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
00852009002451Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
00852009002475Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
00852009002536Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
10197344169450MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-17
09551012610479ELECTROCYN somaV3BIO SDN. BHD.FRO2026-07-16
10197344176007MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-13
10197344176014MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-13
10197344176021MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-13
10197344176038MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-13
04260056880650BLASTXOSARTIS GmbHFRO2026-07-12
00850088144604CARBOUNingbo kehu Medical Technology Co.,Ltd.FRO2026-07-10
00850088144611CARBOUNingbo kehu Medical Technology Co.,Ltd.FRO2026-07-10
00850088144628CARBOUNingbo kehu Medical Technology Co.,Ltd.FRO2026-07-10