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Surface Applicator Set with Leipzig-style Cone (HDR use only)
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref GM11010080
Identity
- Trade Name
- Surface Applicator Set with Leipzig-style Cone (HDR use only) EUDAMEDFDA UDI
- Generic Name
- General-purpose brachytherapy system applicator, remote-afterloading FDA UDI
- Device Name
- Surface Applicator Set with Leipzig-style Cone EUDAMED
- Model / Reference
- GM11010080 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- GM11010080 FDA UDI
- Primary DI / UDI-DI
- 00816389025196 EUDAMEDFDA UDI
- Basic UDI-DI
- 089947500201056Q5 EUDAMED
- 510(k) Number
- K123815 FDA UDI
- FDA Product Code
- JAQ FDA UDI
- EMDN Code
- Z11010380 BRACHYTHERAPY RADIATION SYSTEMS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- General-purpose brachytherapy system applicator, remote-afterloading FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5700 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
Yes
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
Surface Applicator Set with Leipzig-style Cone (HDR use only) by Varian Medical Systems, Inc — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA…
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 | K162018 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K123815 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 089947500201056Q5 | 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 90090d45-56dc-43f4-bf8f-38f8ca66b2b8 61 fields · synced Jul 11, 2026
- FDA UDI 95013d2e-d7fe-4538-beab-54316b1291fb 34 fields · synced May 29, 2026
- FDA 510(k) K162018 1 fields · synced May 18, 2026