Identity
- Trade Name
- Sophysa FDA UDI
- Generic Name
- Cerebrospinal fluid shunt valve programmer FDA UDI
- Device Name
- POLARIS LOCATING INSTRUMENT-3 FDA UDI
- Model / Reference
- PAK3-LI FDA UDI
- Description
- POLARIS LOCATING INSTRUMENT-3 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03760124132120 FDA UDI
- 510(k) Number
- K031097 FDA UDI
- FDA Product Code
- JXG FDA UDI
- GMDN Term
- Cerebrospinal fluid shunt valve programmer 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
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Sophysa 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 3cf85542-2ed7-4d15-bb43-0ad647d09f1e 35 fields · synced Jun 8, 2026