FDA.reportPublic FDA data

Restrata Meshed

Primary DI
00854258006396
Brand
Restrata Meshed
Company
Acera Surgical Inc
Model
RMESH-2.5X7
Device description
Restrata is a sterile, single use device.
Published
2026-04-15
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
QSZAbsorbable Synthetic Wound Dressing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QSZAbsorbable Synthetic Wound DressingUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854258006396PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854258006396008542580063968542580063960854258006396

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.

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
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
00854258006105Restrata Wound MatrixRWM1-5X72022-04-21
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

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
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
04260184022137Suprathel® CWPolymedics Innovations GmbHQSZ2024-10-11