FDA.reportPublic FDA data

Cerafix® Dura Substitute

Primary DI
00854258006006
Brand
Cerafix® Dura Substitute
Company
Acera Surgical Inc
Model
C1-1X1
Device description
Cerafix® Dura Substitute is a resorbable implant for repair of dural defects and is to be used with tensionless sutures. Cerafix® Dura Substitute is a soft, white, pliable,nonfriable, porous polymer matrix.
Published
2017-03-07
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

Product Codes#

Code, Name table
CodeName
GXQDura Substitute

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXQDura SubstituteNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854258006006PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854258006006008542580060068542580060060854258006006

GMDN Terms#

Term, Definition table
TermDefinition
Dura mater graft, syntheticA sterile device made from synthetic polymers [e.g., expanded polytetrafluoroethylene (ePTFE), ePTFE/elastic fluoropolymer) intended to be used for the temporary or permanent repair or replacement of the dura mater in a recipient during a neurosurgical procedure. Restoration of the dura mater maintains the integrity of the brain and spinal cord, and helps prevent leakage of the cerebrospinal fluid (CSF). This dural graft is typically overlaid on the patient's dura; it is typically supplied in the form of a patch and may be sutured into place.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length1Inch
Length2.5Centimeter
Width1Inch
Width2.5Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
040631370
Device count
1

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
00854258006013Cerafix® Dura SubstituteC1-1X32017-03-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10381780541387Durepair®Integra Lifesciences CorporationGXQ2026-03-11
10381780541400Durepair®Integra Lifesciences CorporationGXQ2026-03-11
10381780541417Durepair®Integra Lifesciences CorporationGXQ2026-03-11
10381780541370Durepair®Integra Lifesciences CorporationGXQ2026-03-11
10381780541394Durepair®Integra Lifesciences CorporationGXQ2026-03-11
10381780541424Durepair®Integra Lifesciences CorporationGXQ2026-03-11
00813954027210DuraMatrix RepairCOLLAGEN MATRIX, INC.GXQ2025-12-10
00813954027227DuraMatrix RepairCOLLAGEN MATRIX, INC.GXQ2025-12-10
00813954027234DuraMatrix RepairCOLLAGEN MATRIX, INC.GXQ2025-12-10
00813954027241DuraMatrix RepairCOLLAGEN MATRIX, INC.GXQ2025-12-10
00813954027258DuraMatrix RepairCOLLAGEN MATRIX, INC.GXQ2025-12-10
00813954027265DuraMatrix RepairCOLLAGEN MATRIX, INC.GXQ2025-12-10
00813954027432DuraMatrix-Onlay ConformCOLLAGEN MATRIX, INC.GXQ2025-09-30
00810179630003DURASISCOOK BIOTECH INCORPORATEDGXQ2025-02-20
00810179630010DURASISCOOK BIOTECH INCORPORATEDGXQ2025-02-20
00810179630027DURASISCOOK BIOTECH INCORPORATEDGXQ2025-02-20
00810179630034DURASISCOOK BIOTECH INCORPORATEDGXQ2025-02-20
10381780540762Durepair™TEI BIOSCIENCES INC.GXQ2025-01-31
10381780540823Durepair™TEI BIOSCIENCES INC.GXQ2025-01-31
10381780540786Durepair™TEI BIOSCIENCES INC.GXQ2025-01-31
10381780540854Durepair™TEI BIOSCIENCES INC.GXQ2025-01-31
10381780540878Durepair™TEI BIOSCIENCES INC.GXQ2025-01-31
10381780540892Durepair™TEI BIOSCIENCES INC.GXQ2025-01-31
10827002349770BiodesignCOOK BIOTECH INCORPORATEDGXQ2024-06-28
10827002349787BiodesignCOOK BIOTECH INCORPORATEDGXQ2024-06-28
10827002349794BiodesignCOOK BIOTECH INCORPORATEDGXQ2024-06-28
10827002349800BiodesignCOOK BIOTECH INCORPORATEDGXQ2024-06-28
10827002310909BiodesignCOOK BIOTECH INCORPORATEDGXQ2024-06-28
10827002310916BiodesignCOOK BIOTECH INCORPORATEDGXQ2024-06-28
10827002310923BiodesignCOOK BIOTECH INCORPORATEDGXQ2024-06-28