Identity
- Trade Name
- StrataVarius FDA UDI
- Generic Name
- Cerebrospinal fluid shunt valve programmer FDA UDI
- Device Name
- TOOL 45809 STRATAVARIUS ADJUSTMENT FDA UDI
- Model / Reference
- 45809 FDA UDI
- Description
- TOOL 45809 STRATAVARIUS ADJUSTMENT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000266981 FDA UDI
- 510(k) Number
- K041992 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
- 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Cerebrospinal fluid shunt valve programmer
StrataVarius by Medtronic PS Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K041992 also covers:
- StrataVarius — Medtronic PS Medical
- StrataVarius — Medtronic PS Medical
- StrataVarius® — Medtronic PS Medical
- StrataVarius® — Medtronic PS Medical
- StrataVarius® — Medtronic PS Medical
- StrataVarius® — Medtronic PS Medical
- Strata® — Medtronic PS Medical
- Strata® — Medtronic PS Medical
- Strata® — Medtronic PS Medical
- Strata® — Medtronic PS Medical
- Strata™ — Medtronic PS Medical
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
- Medtronic PS Medical
Sources (1)
- FDA UDI 28cba359-4ba5-4723-9983-592f605bf32a 35 fields · synced May 31, 2026