Identity
- Trade Name
- PULSE EUDAMEDFDA UDI
- Generic Name
- Orthopaedic stereotactic surgery system FDA UDI
- Device Name
- Arrays, Reusable EUDAMEDPULSE CIOS Array, Left Large FDA UDI
- Model / Reference
- Arrays, Reusable EUDAMED5050206 EUDAMEDFDA UDI
- Description
- PULSE CIOS Array, Left Large FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00195377153814 EUDAMEDFDA UDI
- Basic UDI-DI
- 0887517ARRAYR3T EUDAMED
- Direct Marketing DI
- 00195377153814 EUDAMED
- 510(k) Number
- K210574 FDA UDI
- FDA Product Code
- ETN FDA UDIOLO FDA UDIOWB FDA UDIPDQ FDA UDIGWF FDA UDIHAW FDA UDIIKN FDA UDILLZ FDA UDI
- EMDN Code
- Z12011480 SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Orthopaedic stereotactic surgery system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 874.1820 FDA UDI882.4560 FDA UDI892.1650 FDA UDI882.1870 FDA UDI890.1375 FDA UDI892.2050 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Neurological stereotactic surgery system
Pulse by Nuvasive, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0887517ARRAYR3T | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- NuVasive, LLC
- EUDAMED SRN
- US-MF-000007421
- Authorised Representative
- AJW Technology Consulting GmbH DE-AR-000004999
Sources (2)
- EUDAMED 16973fbe-01fd-4506-aa3b-65319078c77f 61 fields · synced Jul 9, 2026
- FDA UDI 20300b6f-6844-47c5-b663-6451ecd4be37 35 fields · synced May 30, 2026