Identity
- Trade Name
- Sophysa FDA UDI
- Generic Name
- Cerebrospinal fluid shunt valve FDA UDI
- Device Name
- SOPHY MINI PROG.VALVE/8.PRESS. ANTICHAMBER FDA UDI
- Model / Reference
- SM8A FDA UDI
- Description
- SOPHY MINI PROG.VALVE/8.PRESS. ANTICHAMBER FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03760124131215 FDA UDI
- 510(k) Number
- K013488 FDA UDI
- FDA Product Code
- JXG FDA UDI
- GMDN Term
- Cerebrospinal fluid shunt valve FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5550 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
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 Conditional FDA UDI
Category: Cerebrospinal fluid shunt valve
Sophysa by Sophysa SA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cerebrospinal fluid shunt valve.
- Mini Integra® — Integra Lifesciences Corp. · Class II
- BioGlide® — Medtronic PS Medical · Class II
- UltraVS™ — Integra Lifesciences Corp. · Class II
- Integra® — Integra Lifesciences Corp. · Class II
- Delta® — Medtronic PS Medical · Class II
- Strata® — Medtronic PS Medical · Class II
- GAV 2.0 — AESCULAP, INC. · Class II
- miniNAV® — Christoph Miethke GmbH & Co. KG · Class II
Cleared under the same submission
K013488 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sophysa SA
Sources (1)
- FDA UDI cb021b20-f1f1-4f02-92e7-7990b8b9a95b 34 fields · synced May 30, 2026