FDA.reportPublic FDA data

DuraMatrix-Onlay Plus

Primary DI
00813954021294
Brand
DuraMatrix-Onlay Plus
Company
COLLAGEN MATRIX, INC.
Model
DMOP33
Device description
Collagen Dural Regeneration Membrane 3in x 3in (7.5cm x 7.5cm)
Published
2016-03-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
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
00813954021294PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813954021294008139540212948139540212940813954021294

GMDN Terms#

Term, Definition table
TermDefinition
Dura mater biomatrix implantA sterile device made of animal-derived collagen (e.g., equine, porcine) designed to temporarily substitute for dura mater during surgical repair or replacement of dura, and to function as a matrix for the regeneration of living dura. Restoration of the dura mater maintains the integrity of the brain and spinal cord, and helps prevent leakage of the cerebrospinal fluid (CSF). The device is typically in the form of a transparent foil that usually requires no suturing and may be used with fibrin sealant.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length3Inch
Width3Inch

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
176262442
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00813954028767Gibson Healthcare Alloplast6247-9926247-9922026-05-26
00813954028774Gibson Healthcare Alloplast6248-0086248-0082026-05-26
00813954028781Gibson Healthcare Alloplast6248-0176248-0172026-05-26
00813954028873PuraKOTE+PGKTE+PGKTE+2026-05-26
00813954028880PuraPLUG+PGPLG+PGPLG+2026-05-26
00813954028897PuraTAPE+PGTPE+PGTPE+2026-05-26
00813954028590bioMAINTAINOUSA1EUOUSA1EU2026-03-23
00813954028606bioMAINTAINOUSA2EUOUSA2EU2026-03-23
00813954028613bioMAINTAINOUSA3EUOUSA3EU2026-03-23
00813954028484XENOFY-PXFP-050050XFP-0500502026-03-12
00813954028491XENOFY-PXFP-050100XFP-0501002026-03-12
00813954028507XENOFY-PXFP-050200XFP-0502002026-03-12
00813954028514XENOFY-PXFP-050400XFP-0504002026-03-12
00813954028521XENOFY-PXFP-051100XFP-0511002026-03-12
00813954028538XENOFY-PXFP-051200XFP-0512002026-03-12
10813954028436Tissue Specialists Resorbable Collagen PlugT5094000T50940002026-03-09
10813954028443Tissue Specialists Resorbable Collagen TapeT5091000T50910002026-03-09
00813954028453Tissue Specialists Resorbable Collagen MembraneT5096000T50960002026-03-09
00813954028460Tissue Specialists Resorbable Collagen MembraneT5093000T50930002026-03-09
00813954028477Tissue Specialists Resorbable Collagen MembraneT5098000T50980002026-03-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10381780541370Durepair®Integra Lifesciences CorporationGXQ2026-03-11
10381780541394Durepair®Integra Lifesciences CorporationGXQ2026-03-11
10381780540823Durepair®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
00810179630003DURASISCOOK BIOTECH INCORPORATEDGXQ2025-02-20
00810179630010DURASISCOOK BIOTECH INCORPORATEDGXQ2025-02-20
00810179630027DURASISCOOK BIOTECH INCORPORATEDGXQ2025-02-20
00810179630034DURASISCOOK BIOTECH INCORPORATEDGXQ2025-02-20
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
07290019685005ArtiFascia®NURAMI MEDICAL LTDGXQ2024-03-14
07290019685012ArtiFascia®NURAMI MEDICAL LTDGXQ2024-03-14
07290019685029ArtiFascia®NURAMI MEDICAL LTDGXQ2024-03-14
00813954026077DuraMatrix-Onlay ConformCOLLAGEN MATRIX, INC.GXQ2024-02-22
00813954026084DuraMatrix-Onlay ConformCOLLAGEN MATRIX, INC.GXQ2024-02-22
00813954026091DuraMatrix-Onlay ConformCOLLAGEN MATRIX, INC.GXQ2024-02-22
00813954026107DuraMatrix-Onlay ConformCOLLAGEN MATRIX, INC.GXQ2024-02-22
00813954026114DuraMatrix-Onlay ConformCOLLAGEN MATRIX, INC.GXQ2024-02-22