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Flexible Fixation Device for Gynecological Applicators
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref GM11001960
Identity
- Trade Name
- Flexible Fixation Device for Gynecological Applicators EUDAMEDFDA UDI
- Generic Name
- Vaginal brachytherapy system applicator, remote-afterloading FDA UDI
- Device Name
- Flexible Fixation Device for Gynecological Applicators EUDAMED
- Model / Reference
- GM11001960 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- GM11001960 FDA UDI
- Primary DI / UDI-DI
- 00816389022119 EUDAMEDFDA UDI
- Basic UDI-DI
- 089947500201091Q7 EUDAMED
- 510(k) Number
- K033371 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 I 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Flexible Fixation Device for Gynecological Applicators by Varian Medical Systems, Inc. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
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 | K240495 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 089947500201091Q7 | 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 0c95127a-4788-4c4e-bbeb-3492d7f3dcfe 61 fields · synced Jun 18, 2026
- FDA UDI c5dd757b-57bc-44c4-b414-95bf64b5c91a 34 fields · synced May 30, 2026
- FDA 510(k) K240495 1 fields · synced May 18, 2026