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Head Frame Kit
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref P1006823005510(k) K180586
Identity
- Trade Name
- Head Frame Kit EUDAMEDFDA UDI
- Generic Name
- Stereotactic radiosurgical invasive head frame FDA UDI
- Device Name
- HeadFrame EUDAMED
- Model / Reference
- P1006823005 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00858086006634 EUDAMEDFDA UDI
- Basic UDI-DI
- 089947500200111PD EUDAMED
- 510(k) Number
- K180586 FDA UDI
- FDA Product Code
- IYE FDA UDI
- EMDN Code
- Z11010780 RADIOSURGERY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Stereotactic radiosurgical invasive head frame FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5050 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
No
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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Head Frame Kit by Varian Medical Systems, Inc. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K142560 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K180586 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 089947500200111PD | Class IIa | Active |
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Manufacturer
- Manufacturer
- Varian Medical Systems, Inc.
- EUDAMED SRN
- US-MF-000001784
- Authorised Representative
- Siemens Healthineers Nederland B.V. NL-AR-000000803
Sources (3)
- EUDAMED b069bb90-b1dc-440d-9f56-0e137c972c99 85 fields · synced Jun 19, 2026
- FDA UDI f4142c56-d128-4419-8886-46e22e5647c7 33 fields · synced May 30, 2026
- FDA 510(k) K142560 1 fields · synced May 18, 2026