Medium fixed template, size 150 mm
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Medium fixed template, size 150 mm EUDAMEDFDA UDI
- Generic Name
- General-purpose brachytherapy system applicator, remote-afterloading FDA UDI
- Device Name
- Advanced Breast Template System EUDAMED
- Model / Reference
- AL07377000 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- AL07377000 FDA UDI
- Primary DI / UDI-DI
- 00810563023213 EUDAMED00816389020740 FDA UDI
- Basic UDI-DI
- 089947500201029Q2 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 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
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Dimensions & Sizes
- Size
- Length — 150 Millimeter FDA UDI
Category: General-purpose brachytherapy system applicator, remote-afterloading
Medium fixed template, size 150 mm by Varian Medical Systems Deutschland GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
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Also classified as General-purpose brachytherapy system applicator, remote-afterloading.
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Varian Medical Systems Deutschland GmbH
Sources (2)
- FDA UDI a5db7dd9-3072-48f5-942f-89f9deb04e20 34 fields · synced Jul 21, 2026
- EUDAMED bace7a4e-fdc3-44c7-be90-33b197539a33 61 fields · synced Jul 21, 2026