Identity
- Trade Name
- Phoenix Neuro FDA UDI
- Generic Name
- Ventriculo-peritoneal/atrial shunt FDA UDI
- Device Name
- Single Valve Kit, Medium Pressure FDA UDI
- Model / Reference
- PV070K FDA UDI
- Description
- Single Valve Kit, Medium Pressure FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03760124136944 FDA UDI
- 510(k) Number
- K853363 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Phoenix Neuro by Sophysa SA — 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
- Sophysa SA
Sources (1)
- FDA UDI 00cea963-44d8-43b3-a9ef-ed5413e7c108 35 fields · synced May 30, 2026