FDA.reportPublic FDA data

Adherus

Primary DI
07613327697469
Brand
Adherus
Company
Stryker Leibinger GmbH & Co. KG
Model
NUS-109-01
Catalog number
NUS-109-01
Device description
Adherus AutoSpray ET Dural Sealant
Published
2026-08-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

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
07613327697469PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327697469076133276974697613327697469

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 Atmospheric Pressure00
Storage Environment Humidity00
Storage Environment Temperature00

Regulatory Flags#

DUNS number
316153956
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
true
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
07613327097627CranialMask Tracker6000-390-0006000-390-0002017-03-13
07613327499711N/A8900-200-2008900-200-2002023-03-23
07613327551938N/A6002-710-0506002-710-0502022-07-26
07613327620306N/A6002-810-5006002-810-5002025-10-28
07613327616118N/A6002-810-0006002-810-0002024-08-22
07613327616255N/A6002-810-3006002-810-3002024-08-15
07613327616286N/A81-8104481-810442024-08-15
07613327638189N/A6002-810-1006002-810-1002024-08-15
07613327638196N/A6002-810-2006002-810-2002024-08-15
07613327579833N/A7000015775827000015775822024-08-07
07613327576542N/A8800-100-0008800-100-0002023-04-11
07613327500530N/A8000-060-0198000-060-0192023-03-24
07613327500615N/A8000-060-0168000-060-0162023-03-23
07613327500622N/A8000-060-0148000-060-0142023-03-23
07613327500639N/A8000-060-0158000-060-0152023-03-23
07613327500646N/A8000-060-0188000-060-0182023-03-23
07613327538328Cranial Guidance Software81-8104281-810422023-03-23
07613327538410Cranial Guidance Software6000-670-3006000-670-3002023-03-23
07613327500509N/A8000-040-0178000-040-0172023-03-22
07613327500523N/A8000-040-0188000-040-0182023-03-22

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
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