FDA.reportPublic FDA data

Durepair™

Primary DI
10381780540762
Brand
Durepair™
Company
TEI BIOSCIENCES INC.
Model
62106
Catalog number
62106
Device description
"Durepair™ 2.5cm x 7.5cm (1"" x 3"")"
Published
2025-01-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169063877PreviousGS10
10381780540762PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169063877006431690638776431690638770643169063877
1038178054076210381780540762

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
Length3Inch
Length7.5Centimeter
Width1Inch
Width2.5Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not use if package is damaged
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature35 Degrees Fahrenheit86 Degrees Fahrenheit

Contacts#

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

Regulatory Flags#

DUNS number
796253292
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780540823Durepair™62110621102025-01-31
10381780540786Durepair™62158621582025-01-31
10381780540854Durepair™62100621002025-01-31
10381780540878Durepair™62111621112025-01-31
10381780540892Durepair™62105621052025-01-31
10381780113317PriMatrix®607-001-125607-001-1252015-10-21
10381780113294PriMatrix®607-001-009607-001-0092015-10-21
10381780113300PriMatrix®607-001-112607-001-1122015-10-21
10381780113324PriMatrix®607-001-225607-001-2252015-10-21
10381780113331PriMatrix®607-001-440607-001-4402015-10-21
10381780113348PriMatrix®607-001-660607-001-6602015-10-21
10381780113355PriMatrix®607-001-812607-001-8122015-10-21
10381780113362PriMatrix®607-001-880607-001-8802015-10-21
10381780113379PriMatrix®607-004-440607-004-4402015-10-21
10381780113386PriMatrix®607-004-660607-004-6602015-10-21
10381780113393PriMatrix®607-004-880607-004-8802015-10-21
10381780113409PriMatrix®607-005-125607-005-1252015-10-23
10381780113416PriMatrix®607-005-220607-005-2202015-10-21
10381780113423PriMatrix®607-005-225607-005-2252015-10-21
10381780113430PriMatrix®607-005-330607-005-3302015-10-21

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
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
10827002324371BiodesignCOOK BIOTECH INCORPORATEDGXQ2024-06-28