FDA.reportPublic FDA data

Biodesign

Primary DI
10827002310909
Brand
Biodesign
Company
COOK BIOTECH INCORPORATED
Model
G31090
Catalog number
C-DUR-4X7
Device description
Biodesign Dural Graft
Published
2024-06-28
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K031850000
K160869000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K031850000DURASIS DURAL SUBSTITUTECook Biotech, Inc.2003-09-08GXQ
K160869000Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair GraftCook Biotech Incorporated2016-04-29FTM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10827002310909PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1082700231090910827002310909

GMDN Terms#

Term, Definition table
TermDefinition
Dura mater biomatrix implantA bioabsorbable 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry.
Special Storage Condition, Specify00Store in clean, dry location at controlled room temperature. Do not freeze.
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(812)330-5494sharedservices@cookmedical.com

Regulatory Flags#

DUNS number
945385862
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10827002311418BiodesignG31141C-IHM-10X152015-11-03
10827002314518BiodesignG31451C-IHM-6X13-P2015-11-03
10827002314525BiodesignG31452C-IHM-8X15-P2015-11-03
00827002231191OASISG231198213-0000-132019-03-11
00827002352421OASISG352428213-0000-162019-03-11
00827002352438OASISG352438213-0000-172019-03-12
00827002352445OASISG352448213-0000-182019-03-11
00827002352452OASISG352458213-0000-192019-03-11
00827002466227OASISG466228213-1000-332019-03-11
00827002466234OASISG466238213-2000-332019-04-17
00827002466265OASISG466268213-1000-372019-03-11
00827002466272OASISG466278213-2000-372019-04-17
00827002564633OASISG564638213-0000-092019-03-11
00827002564657OASISG564658213-0000-112019-03-11
00827002576018OASISG576018213-3000-092019-03-11
00827002576025OASISG576028213-3000-112019-03-11
00827002576032OASISG576038213-3000-132019-03-11
00827002576049OASISG576048213-3000-162019-03-11
00827002576056OASISG576058213-3000-172019-03-11
00827002576063OASISG576068213-3000-182019-03-11

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
10827002310916BiodesignCOOK BIOTECH INCORPORATEDGXQ2024-06-28
10827002310923BiodesignCOOK BIOTECH INCORPORATEDGXQ2024-06-28
10827002324371BiodesignCOOK BIOTECH INCORPORATEDGXQ2024-06-28