FDA.reportPublic FDA data

DuraSeal®

Primary DI
10381780000013
Brand
DuraSeal®
Company
Integra Lifesciences Corporation
Model
202010DS
Catalog number
202010DS
Device description
DuraSeal® Dural Sealant System Polymer Kit
Published
2015-06-05
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
NQRSealant, Dural

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NQRSealant, DuralUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P040034024

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P040034024DURASEAL DURAL SEALANT SYSTEMIntegra LifeSciences Corporation2005-04-07NQR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780000013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178000001310381780000013

GMDN Terms#

Term, Definition table
TermDefinition
Dura mater sealantAn implanted bioabsorbable material (e.g., solution, gel, spray, patch) intended to be applied to a defect in the dura mater, possibly as an adjunct to standard methods of closure (e.g., suturing), to prevent cerebrospinal fluid (CSF) leakage during healing. The material primarily consists of synthetic polymers that subsequently form adhesive bonds with the dura mater and eventually degrade and are absorbed. After application, this device cannot be reused.

Device Sizes#

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Celsius25 Degrees Celsius
Handling Environment Temperature0 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
083171244
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
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
00860010683729SpineSeal Spine SealantPramand LLCNQR2025-03-03
20860010683723SpineSeal Spine SealantPramand LLCNQR2025-03-03
10381780537168DuraSeal® ExactIntegra Lifesciences CorporationNQR2025-02-17
10381780537175DuraSeal®Integra Lifesciences CorporationNQR2025-02-17
10381780542186DuraSeal® ExactIntegra Lifesciences CorporationNQR2025-02-17
30381780537162DuraSeal® ExactIntegra Lifesciences CorporationNQR2025-02-17
30381780537179DuraSeal®Integra Lifesciences CorporationNQR2025-02-17
10381780542179DuraSeal®Integra Lifesciences CorporationNQR2025-02-17
30381780542180DuraSeal® ExactIntegra Lifesciences CorporationNQR2025-02-17
00860010683705CraniSeal Dural SealantPramand LLCNQR2023-08-15
00860010683712CraniSeal Dural SealantPramand LLCNQR2023-08-15
10381780000037DuraSeal Exact Spinal Sealant SystemIntegra Lifesciences CorporationNQR2016-12-29
10381780000044DuraSeal Exact Spinal Sealant SystemIntegra Lifesciences CorporationNQR2016-12-29
10381780000020DuraSeal®Integra Lifesciences CorporationNQR2016-12-29
30381780000031DuraSeal Exact Spinal Sealant SystemIntegra Lifesciences CorporationNQR2016-12-29
30381780000048DuraSeal Exact Spinal Sealant SystemIntegra Lifesciences CorporationNQR2016-12-29
00897146002025Adherus STRYKER CORPORATIONNQR2016-12-19
30897146002026Adherus AutoSpray ET Dural SealantHYPERBRANCH MEDICAL TECHNOLOGY, INC.NQR2016-12-19
08971460020315Adherus AutoSpray ET Dural SealantHYPERBRANCH MEDICAL TECHNOLOGY, INC.NQR2016-12-19
00897146002018Adherus STRYKER CORPORATIONNQR2015-04-14
08971460020261Adherus AutoSpray Dural SealantHYPERBRANCH MEDICAL TECHNOLOGY, INC.NQR2015-04-14
10884521056411DurasealCovidien LPNQR2014-09-22
20884521056371DurasealCovidien LPNQR2014-09-22
20884521056388DurasealCovidien LPNQR2014-09-22
20884521056432DurasealCovidien LPNQR2014-09-22