FDA.reportPublic FDA data

SpineSeal Spine Sealant

Primary DI
00860010683729
Brand
SpineSeal Spine Sealant
Company
Pramand LLC
Model
SS-2055
Catalog number
SS-2055
Device description
The SpineSeal Spine Sealant is indicated as an adjuct to sutured dural repair during spine surgery to provide a watertight closure.
Published
2025-03-03
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

Product Codes#

Code, Name table
CodeName
NQRSealant, Dural

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NQRSealant, DuralUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P240027000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P240027000SpineSeal Spine SealantPramand, LLC2025-02-14NQR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860010683729PrimaryGS10
20860010683723Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860010683729008600106837298600106837290860010683729
2086001068372320860010683723

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius25 Degrees Celsius

Regulatory Flags#

DUNS number
117587283
Device count
5
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860010683705CraniSeal Dural SealantCS-2055CS-20552023-08-15
20860010683723SpineSeal Spine SealantSS-2055SS-20552025-03-03
00860010683712CraniSeal Dural SealantCS-2015CS-20152023-08-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10381780000013DuraSeal®Integra Lifesciences CorporationNQR2015-06-05
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