Identity
- Trade Name
- SyntheCel FDA UDI
- Generic Name
- Dura mater graft, bioengineered FDA UDI
- Device Name
- SYNTHECEL® DURA REPAIR 2.5CM X 2.5CM(1" X 1")STERILE FDA UDI
- Model / Reference
- SC.400.006.01S FDA UDI
- Description
- SYNTHECEL® DURA REPAIR 2.5CM X 2.5CM(1" X 1")STERILE FDA UDI
Identifiers
- Catalog Number
- SC40000601S FDA UDI
- Primary DI / UDI-DI
- 10887587001357 FDA UDI
- FDA Product Code
- GXQ FDA UDI
- GMDN Term
- Dura mater graft, bioengineered FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5910 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
MR Safe FDA UDI
Category: Dura mater graft, bioengineered
SyntheCel by Synthes — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dura mater graft, bioengineered.
Cleared under the same submission
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 II | Pending data |
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Manufacturer
- Manufacturer
- Synthes
Sources (1)
- FDA UDI 1a890af9-779a-4f03-9b48-f39a7e8b5341 37 fields · synced Jun 8, 2026