Identity
- Trade Name
- CraniSeal Dural Sealant FDA UDI
- Generic Name
- Dura mater sealant FDA UDI
- Device Name
- The CraniSeal Dural Sealant is indicated for use in patients greater than or equal to 18 years of age as an adjunct to sutured dural repair during cranial surgery to provide a watertight closure. FDA UDI
- Model / Reference
- CS-2055 FDA UDI
- Description
- The CraniSeal Dural Sealant is indicated for use in patients greater than or equal to 18 years of age as an adjunct to sutured dural repair during cranial surgery to provide a watertight closure. FDA UDI
Identifiers
- Catalog Number
- CS-2055 FDA UDI
- Primary DI / UDI-DI
- 00860010683705 FDA UDI
- PMA Number
- P220014 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
Dimensions & Sizes
- Size
- Total Volume — 5 Milliliter FDA UDI
Category: Dura mater sealant
CraniSeal Dural Sealant by Pramand, LLC — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dura mater sealant.
- DuraSeal® — Integra Lifesciences Corp. · 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
- Better Touch — CENTRAL ASSOCIATION FOR THE BLIND, INC. · Class I
- DuraSeal® — Integra Lifesciences Corp. · Class III
- DuraSeal® — Integra Lifesciences Corp. · Class III
- Adherus AutoSpray ET Dural Sealant — HYPERBRANCH MEDICAL TECHNOLOGY INC · 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 III | Pending data |
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Manufacturer
- Manufacturer
- Pramand, LLC
Sources (1)
- FDA UDI fc4212d9-12f7-4b2f-960c-7cab3d5c9d00 38 fields · synced May 30, 2026