Identity
- Trade Name
- CODMAN CERTAS BACTISEAL FDA UDI
- Generic Name
- Ventriculo-peritoneal/atrial shunt FDA UDI
- Device Name
- CODMAN CERTAS Plus Programmable Valve Inline Valve with Accessories and Unitized BACTISEAL Catheter Includes: BACTISEAL Ventricular Catheter, BACTISEAL Unitized Distal Catheter, Priming Adapter, Right Angle Adapter and Information Manual FDA UDI
- Model / Reference
- 82-8803PL FDA UDI
- Description
- CODMAN CERTAS Plus Programmable Valve Inline Valve with Accessories and Unitized BACTISEAL Catheter Includes: BACTISEAL Ventricular Catheter, BACTISEAL Unitized Distal Catheter, Priming Adapter, Right Angle Adapter and Information Manual FDA UDI
Identifiers
- Catalog Number
- 828803PL FDA UDI
- Primary DI / UDI-DI
- 10886704079033 FDA UDI
- FDA Product Code
- JXG FDA UDI
- GMDN Term
- Ventriculo-peritoneal/atrial shunt FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5550 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
Yes
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 Conditional FDA UDI
Codman Certas Bactiseal by Medos International Sàrl — 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
- Medos International Sàrl
Sources (1)
- FDA UDI 9f66214e-8319-461f-b1d7-e3c17c113acc 37 fields · synced Jun 1, 2026