FDA.reportPublic FDA data

Restrata(R)

Primary DI
00854258006129
Brand
Restrata(R)
Company
Acera Surgical Inc
Model
RWM1-1X2
Device description
Restrata(R) is a sterile, single use device intended for use in local management of wounds. Restrata(R) is a soft, white, conformable, non-friable, absorbable matrix that provides an environment for the body’s natural healing process to occur.
Published
2019-05-20
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170300000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170300000Restrata Wound MatrixAcera Surgical, Inc.2017-04-26QSZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854258006129PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854258006129008542580061298542580061290854258006129

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
Length5Centimeter
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
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
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
00850067990260Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990352Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990444Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
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