Identity
- Trade Name
- StrataMR II FDA UDI
- Generic Name
- Ventriculoperitoneal shunt FDA UDI
- Device Name
- ASSY 46955MR SHUNT STRATAMR II SMALL FDA UDI
- Model / Reference
- 46955MR FDA UDI
- Description
- ASSY 46955MR SHUNT STRATAMR II SMALL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000422721 FDA UDI
- 510(k) Number
- K212641 FDA UDI
- FDA Product Code
- JXG FDA UDI
- GMDN Term
- Ventriculoperitoneal shunt 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
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 Conditional FDA UDI
Category: Ventriculoperitoneal shunt
StrataMR II by Medtronic PS Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ventriculoperitoneal shunt.
- CODMAN® HAKIM® — Integra LifeSciences Production Corporation · Class II
- Integra® — Integra Lifesciences Corp. · Class II
- Novus™ — Integra Lifesciences Corp. · Class II
- CODMAN® HAKIM® — Integra LifeSciences Production Corporation · Class II
- CODMAN® HAKIM® — Integra LifeSciences Production Corporation · Class II
- CODMAN® HAKIM® — Integra LifeSciences Production Corporation · Class II
- CODMAN® HAKIM® — Integra LifeSciences Production Corporation · Class II
- CODMAN® UNI-SHUNT® — Integra LifeSciences Production Corporation · Class II
Cleared under the same submission
K212641 also covers:
- Snap Shunt Assembly, StrataMR II, Regular — Medtronic PS Medical
- StrataMR — Medtronic PS Medical
- StrataMR — Medtronic PS Medical
- StrataMR — Medtronic PS Medical
- StrataMR II — Medtronic PS Medical
- StrataMR II — Medtronic PS Medical
- StrataMR II — Medtronic PS Medical
- StrataMR II — Medtronic PS Medical
- StrataMR II — Medtronic PS Medical
- StrataMR II — Medtronic PS Medical
- StrataMR II — Medtronic PS Medical
- StrataMR II — 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 8118f207-c442-469a-8de4-d2c901d1f0b4 35 fields · synced May 31, 2026