FDA.reportPublic FDA data

DuraGen® Plus

Primary DI
10381780023487
Brand
DuraGen® Plus
Company
Integra Lifesciences Corporation
Model
DP1057
Catalog number
DP-1057
Device description
DuraGen® Plus Dural Regeneration Matrix, 5 in x 7 in (12.5 cm x 17.5 cm)
Published
2015-09-22
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXQDURA SUBSTITUTE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXQDura SubstituteNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K032693000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K032693000DURAGEN PLUS DURAL GRAFT MATRIXIntegra Lifesciences Corp.2003-09-30GXQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780023487PrimaryGS10
M269DP10571SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178002348710381780023487

GMDN Terms#

Term, Definition table
TermDefinition
Dura mater graft, bovineA xenograft made from bovine dura mater or bovine pericardium used for the 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 and resorbs within 9 to 12 months after surgery. It may be supplied in strips of various sizes and shapes (e.g., square or rectangular) and in a sterile, dry state with treated surfaces.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
083171244
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780272618Omni-Tract®11908119082018-02-23
20705031004334BioPatch™31502016-06-20
20705031004341BioPatch™31512016-06-20
20705031004358BioPatch™31522016-06-20
10381780541387Durepair®62105621052026-03-11
10381780541400Durepair®62110621102026-03-11
10381780541417Durepair®62111621112026-03-11
10381780541370Durepair®62100621002026-03-11
10381780541394Durepair®62106621062026-03-11
10381780541424Durepair®62158621582026-03-11
10381780537434Hermetic™ PlusINS8301INS83012024-06-28
10381780253549MAYFIELD®A1114A11142016-07-26
10381780253556MAYFIELD®A1114AA1114A2016-07-26
10381780268666Omni-Tract®3121R3121R2018-02-23
10381780269953Omni-Tract®3810R3810R2018-02-23
10381780270072Omni-Tract®3858R3858R2018-02-23
10381780270393Omni-Tract®392239222018-02-23
10381780374121AccuDrain®SP02202017-05-08
10381780542254MAYFIELD®A4000PA4000P2026-02-05
10381780542261MAYFIELD®A4000SRLA4000SRL2026-02-05

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