FDA.reportPublic FDA data

Restrata Wound Matrix

Primary DI
00854258006105
Brand
Restrata Wound Matrix
Company
Acera Surgical Inc
Model
RWM1-5X7
Device description
The Restrata Wound Matrix is a sterile, single use device intended for use in local management of wounds.
Published
2022-04-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854258006105PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854258006105008542580061058542580061050854258006105

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
040631370
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00854258006389Restrata(R)RWM1-2.5X72026-04-15
00854258006396Restrata MeshedRMESH-2.5X72026-04-15
00854258006310Restrata MiniMatrixRMINI-1002023-06-29
00854258006327Restrata MiniMatrixRMINI-2502023-06-29
00854258006334Restrata MiniMatrixRMINI-5002023-06-29
00854258006341Restrata MiniMatrixRMINI-10002023-06-29
00854258006358Restrata MiniMatrixRMINI-20002023-06-29
00854258006242Restrata Wound MatrixRWM1-0.5X12022-04-21
00854258006259Restrata Wound MatrixRWM1-1.5X22022-04-21
00854258006266Restrata MeshedRMESH-1.5X22022-04-21
00854258006273Restrata MeshedRMESH-2X22022-04-21
00854258006280Restrata MeshedRMESH-3X32022-04-21
00854258006297Restrata MeshedRMESH-4X52022-04-21
00854258006303Restrata MeshedRMESH-5X72022-04-21
00854258006204CovoraTMCOV1-5X52019-10-04
00854258006211CovoraTMCOV1-7.5X7.52019-10-04
00854258006228CovoraTMCOV1-10X12.52019-10-04
00854258006129Restrata(R)RWM1-1X22019-05-20
00854258006006Cerafix® Dura SubstituteC1-1X12017-03-07
00854258006013Cerafix® Dura SubstituteC1-1X32017-03-07

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00850088144635CARBOUNingbo kehu Medical Technology Co.,Ltd.FRO2026-07-10
00850019138146SilverSealNEXGEL Inc.FRO2026-07-08
00850019138153TurfGuardNEXGEL Inc.FRO2026-07-08
00850019138443SilverSealNEXGEL Inc.FRO2026-07-08
00850019138474SilverSealNEXGEL Inc.FRO2026-07-08
00850019138511SilverSealNEXGEL Inc.FRO2026-07-08
00850067990086Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990178Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
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00850067990536Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990628Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990710Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990802Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06