Identity
- Trade Name
- CODMAN ETHISORB FDA UDI
- Generic Name
- Dura mater graft, synthetic FDA UDI
- Device Name
- CODMAN ETHISORB Dura Patch Polyglactin 910/poly-p-dioxanone 20mm x 30mm FDA UDI
- Model / Reference
- 83-1143 FDA UDI
- Description
- CODMAN ETHISORB Dura Patch Polyglactin 910/poly-p-dioxanone 20mm x 30mm FDA UDI
Identifiers
- Catalog Number
- 831143 FDA UDI
- Primary DI / UDI-DI
- 10886704042686 FDA UDI
- 510(k) Number
- K991413 FDA UDI
- FDA Product Code
- GXQ FDA UDI
- GMDN Term
- Dura mater graft, synthetic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5910 FDA UDI
- Commercial Distribution
- Not 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
Codman Ethisorb by Cerenovus, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Cerenovus, Inc.
Sources (1)
- FDA UDI 2b174c49-7a77-4580-ba8d-18493db789b9 37 fields · synced Jun 1, 2026