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Intraluminal Applicator Set
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref GM11000620510(k) K242961
Identity
- Trade Name
- Intraluminal Applicator Set EUDAMEDFDA UDI
- Generic Name
- Bronchial brachytherapy system applicator, remote-afterloading FDA UDI
- Device Name
- Intraluminal Applicator Set EUDAMEDFDA UDI
- Model / Reference
- GM11000620 EUDAMEDFDA UDI
- Description
- Intraluminal Applicator Set FDA UDI
Identifiers
- Catalog Number
- GM11000620 FDA UDI
- Primary DI / UDI-DI
- 00810563022834 EUDAMEDFDA UDI
- Basic UDI-DI
- 089947500201093QB EUDAMED
- FDA Product Code
- JAQ FDA UDI
- EMDN Code
- Z11010380 BRACHYTHERAPY RADIATION SYSTEMS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Bronchial 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Intraluminal Applicator Set 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 | K151022 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K242961 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 089947500201093QB | Class IIa | Active |
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Manufacturer
- Manufacturer
- Varian Medical Systems, Inc.
- EUDAMED SRN
- US-MF-000001784
- FDA Applicant
- Varian Medical Systems
- Authorised Representative
- Siemens Healthineers Nederland B.V. NL-AR-000000803
Sources (3)
- EUDAMED 3bf02607-49b4-41dc-bf61-4e6d92ae4c7c 85 fields · synced Jun 18, 2026
- FDA UDI 37082c36-cbed-45d9-9a55-30ea9c67fec7 35 fields · synced May 30, 2026
- FDA 510(k) K151022 1 fields · synced May 18, 2026