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Varian Sterilization Box for Advanced Breast Template System
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref GM11012150Ref AL13012000
Identity
- Trade Name
- Varian Sterilization Box for Advanced Breast Template System EUDAMEDFDA UDIAdvanced Breast Template System EUDAMEDAdvanced Breast Template System - CT FDA UDI
- Generic Name
- General-purpose brachytherapy system applicator, remote-afterloading FDA UDIDevice sterilization/disinfection container, reusable FDA UDI
- Device Name
- Sterilization Boxes EUDAMEDAdvanced Breast Template System EUDAMED
- Model / Reference
- GM11012150 EUDAMEDFDA UDIAL13012000 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- AL13012000 FDA UDIGM11012150 FDA UDI
- Primary DI / UDI-DI
- 00816389028449 EUDAMEDFDA UDI00816389021235 EUDAMEDFDA UDI
- Basic UDI-DI
- 089947500201123PT EUDAMED089947500201029Q2 EUDAMED
- 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 UDIDevice sterilization/disinfection container, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass 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
No
FDA UDIFDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Varian Sterilization Box for Advanced Breast Template System 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 | K161540 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 089947500201123PT | 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 (5)
- EUDAMED 3e705c3a-23bc-433b-a676-1195be101e20 61 fields · synced Jul 12, 2026
- FDA UDI dc566706-76e6-4f3a-b7e1-88a8040d87db 34 fields · synced May 25, 2026
- FDA UDI 60220a3a-b979-4c4b-82f6-25523bc957f1 34 fields · synced May 30, 2026
- EUDAMED f854dd37-c611-45c4-ac05-fc5215bc0b1c 61 fields · synced Jul 12, 2026
- FDA 510(k) K161540 1 fields · synced May 18, 2026