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Titanium Fletcher-style Applicator Set -Defined Geometry
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref GM11006200510(k) K241853
Identity
- Trade Name
- Titanium Fletcher-style Applicator Set -Defined Geometry EUDAMEDTitanium Fletcher style Applicator Set Defined Geometry FDA UDI
- Generic Name
- Vaginal brachytherapy system applicator, remote-afterloading FDA UDI
- Device Name
- Titanium Fletcher-Style Applicator Set—Defined Geometry EUDAMED
- Model / Reference
- GM11006200 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- GM11006200 FDA UDI
- Primary DI / UDI-DI
- 00810563022346 EUDAMEDFDA UDI
- Basic UDI-DI
- 089947500201059QB EUDAMED
- 510(k) Number
- K241853 FDA UDI
- FDA Product Code
- JAQ FDA UDI
- EMDN Code
- Z11010380 BRACHYTHERAPY RADIATION SYSTEMS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Vaginal 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
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
Moist Heat or Steam Sterilization FDA UDI
Titanium Fletcher-style Applicator Set -Defined Geometry by Varian Medical Systems, Inc. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
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 | K241853 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K120731 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 089947500201059QB | 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 26a79bba-67eb-4f6f-9330-7afa07099f64 85 fields · synced Jun 18, 2026
- FDA UDI 9c9183e5-210f-4cbb-b87a-77eea3741eb4 34 fields · synced May 30, 2026
- FDA 510(k) K241853 1 fields · synced Jun 9, 2026