Adherus AutoSpray Dural Sealant

Primary DI
08971460020261
Brand
Adherus AutoSpray Dural Sealant
Company
HYPERBRANCH MEDICAL TECHNOLOGY, INC.
Model
NUS-106
Device description
Adherus AutoSpray Dural Sealant is a sterile, single-use, electromechanical, battery operated, device with internal system components that provide air flow to aid in the delivery of a synthetic, absorbable, two-component hydrogel sealant system and allow delivery to be interrupted without clogging.
Published
2015-04-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08971460020278PackageGS15In Commercial Distribution
08971460020261PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08971460020278089714600202788971460020278
08971460020261089714600202618971460020261

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 Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
9194333325info@hyperbranch.com

Regulatory Flags#

DUNS number
145235953
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30897146002026Adherus AutoSpray ET Dural SealantNUS-1092016-12-19
08971460020315Adherus AutoSpray ET Dural SealantNUS-1092016-12-19

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
10381780000013DuraSeal®Integra Lifesciences CorporationNQR2015-06-05
00897146002018Adherus STRYKER CORPORATIONNQR2015-04-14
10884521056411DurasealCovidien LPNQR2014-09-22
20884521056371DurasealCovidien LPNQR2014-09-22
20884521056388DurasealCovidien LPNQR2014-09-22
20884521056432DurasealCovidien LPNQR2014-09-22