Identity
- Trade Name
- Adherus AutoSpray Dural Sealant FDA UDI
- Generic Name
- Dura mater sealant FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- NUS-106 FDA UDI
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00897146002018 FDA UDI
- PMA Number
- P130014 FDA UDI
- FDA Product Code
- NQR FDA UDI
- GMDN Term
- Dura mater sealant FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dura mater sealant
Adherus AutoSpray Dural Sealant by Hyperbranch Medical Technology Inc — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dura mater sealant.
- SpineSeal Spine Sealant — Pramand, LLC · Class III
- DuraSeal® — Integra Lifesciences Corp. · Class III
- CraniSeal Dural Sealant — Pramand, LLC · Class III
- DuraSeal® — Integra Lifesciences Corp. · Class III
- DuraSeal Exact Spinal Sealant System — Integra Lifesciences Corp. · Class III
- Better Touch — CENTRAL ASSOCIATION FOR THE BLIND, INC. · Class I
- DuraSeal® — Integra Lifesciences Corp. · Class III
- DuraSeal® — Integra Lifesciences Corp. · Class III
Cleared under the same submission
P130014 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Hyperbranch Medical Technology Inc
Sources (1)
- FDA UDI ce233010-f961-4ee7-a0d4-2c2bb733cd44 36 fields · synced Jun 8, 2026