Identity
- Trade Name
- PULSE FDA UDI
- Generic Name
- Diagnostic x-ray digital imaging system workstation FDA UDI
- Device Name
- PULSE LessRay GE C-arm Mount FDA UDI
- Model / Reference
- 1801814 FDA UDI
- Description
- PULSE LessRay GE C-arm Mount FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00195377057020 FDA UDI
- 510(k) Number
- K210574 FDA UDI
- FDA Product Code
- JAA FDA UDIOLO FDA UDIOWB FDA UDIETN FDA UDIPDQ FDA UDIIKN FDA UDILLZ FDA UDIHAW FDA UDIGWF FDA UDI
- GMDN Term
- Diagnostic x-ray digital imaging system workstation FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1650 FDA UDI882.4560 FDA UDI874.1820 FDA UDI890.1375 FDA UDI892.2050 FDA UDI882.1870 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
Category: Diagnostic x-ray digital imaging system workstation
Pulse by Nuvasive, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K210574 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 |
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Manufacturer
- Manufacturer
- Nuvasive, Inc.
Sources (1)
- FDA UDI c010ec40-0ad5-46c7-9fe0-73cd157ae580 35 fields · synced Jun 1, 2026