FDA.reportPublic FDA data

Restrata™ Wound Matrix

Primary DI
00854258006068
Brand
Restrata™ Wound Matrix
Company
Acera Surgical Inc
Model
RWM1-1X1
Device description
The Restrata™ Wound Matrix is a sterile, single use device intended for use in local management of wounds. The Restrata™ Wound Matrix is a soft, white, conformable, non-friable, absorbable matrix that acts as a protective covering for wound defects, providing a moist environment for the body’s natural healing process to occur.
Published
2017-07-24
Public version status
Update
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
00854258006068PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854258006068008542580060688542580060680854258006068

GMDN Terms#

Term, Definition table
TermDefinition
Bioabsorbable wound dressingA sterile wound cover with a bioabsorbable skin contact layer composed of bioengineered/synthetic materials intended to protect a wound and to subsequently be absorbed into the skin as the wound heals. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length2.5Centimeter
Width2.5Centimeter

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
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

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Primary DI, Brand, Company table
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00841277111323Novera RenewHarps USA, Inc.FRO2026-08-26
00850087488723CeeportCEEPORT INC.FRO2026-08-26
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00850087488846CeeportCEEPORT INC.FRO2026-08-26
00850087488853CeeportCEEPORT INC.FRO2026-08-26
00850087488747CeeportCEEPORT INC.FRO2026-08-25
04260056880636BactisureOSARTIS GmbHFRO2026-08-25
05000223503284ACTICOAT FlexSMITH & NEPHEW MEDICAL LIMITEDFRO2026-08-25
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00197998433559Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
04046961025153Prontosan®B. BRAUN MEDICAL INC.FRO2026-08-09
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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