Identity
- Trade Name
- Better Touch FDA UDI
- Generic Name
- Dura mater sealant FDA UDI
- Model / Reference
- 802.3 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815947004390 FDA UDI
- FDA Product Code
- LYY FDA UDI
- GMDN Term
- Dura mater sealant FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6250 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
Yes
FDA UDI
Prescription Use
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dura mater sealant
Better Touch by Central Association For The Blind, Inc. — Class I — 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
- Adherus AutoSpray Dural Sealant — HYPERBRANCH MEDICAL TECHNOLOGY INC · Class III
- DuraSeal® — Integra Lifesciences Corp. · Class III
- DuraSeal Exact Spinal Sealant System — Integra Lifesciences Corp. · Class III
- DuraSeal® — Integra Lifesciences Corp. · Class III
- DuraSeal® — Integra Lifesciences Corp. · Class III
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 I | Pending data |
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Manufacturer
- Manufacturer
- Central Association For The Blind, Inc.
Sources (1)
- FDA UDI 80eb40d9-a01e-4ce9-8f9a-ada1febf3bcb 32 fields · synced Jun 8, 2026