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Gating Reflector Block
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref Gating Reflector Block 1.0
Identity
- Trade Name
- Gating Reflector Block EUDAMEDFDA UDI
- Generic Name
- Real-time position management respiratory gating system, optical FDA UDI
- Device Name
- Marker Blocks EUDAMED
- Model / Reference
- Gating Reflector Block 1.0 EUDAMED1.0 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00856100006226 EUDAMEDFDA UDI
- Basic UDI-DI
- 089947500200109PS EUDAMED
- 510(k) Number
- K242874 FDA UDI
- FDA Product Code
- JAK FDA UDI
- EMDN Code
- Z119080 VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Real-time position management respiratory gating system, optical FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1750 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Gating Reflector Block by Varian Medical Systems, Inc — Class I — 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
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K242874 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 089947500200109PS | Class I | 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 fcf2e3b3-21ce-443c-9a7f-0db0ffca48e2 61 fields · synced Jul 8, 2026
- FDA UDI 23855bc2-2cef-4885-b9dd-5dc4b0d1443d 33 fields · synced May 26, 2026
- FDA 510(k) K242874 1 fields · synced May 18, 2026