FDA.report

DuraMend-Onlay™ Plus

Primary DI
00813954022307
Brand
DuraMend-Onlay™ Plus
Company
COLLAGEN MATRIX, INC.
Model
NDMOP45
Device description
Collagen Dural Regeneration Matrix 4in x 5in (10.0cm x 12.5cm)
Published
2018-04-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
GXQDura Substitute

Product Code Classifications

CodeDeviceSpecialtyClass
GXQDura SubstituteNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00813954022307PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00813954022307008139540223078139540223070813954022307

GMDN Terms

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

TypeValueUnit
Length5Inch
Width4Inch

Sterilization Methods

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 DIBrandModelCatalogPublished
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
10813954028542bioSTRIPOUSTPSOUSTPS2026-03-09
10813954028559bioPLUGOUSPGSOUSPGS2026-03-09
10813954028566bioKOTEOUSKTSOUSKTS2026-03-09
10813954021840PlatFORM CM StripCM46420CM464202016-08-01
00813954027470RCM6509600050960002026-01-07
00813954027487RCM6509300050930002026-01-07

Other Devices Sharing Product Codes

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