Large sliding template, size 200 mm
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Large sliding template, size 200 mm EUDAMEDFDA UDI
- Generic Name
- General-purpose brachytherapy system applicator, remote-afterloading FDA UDI
- Device Name
- Advanced Breast Template System EUDAMED
- Model / Reference
- AL07381000 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- AL07381000 FDA UDI
- Primary DI / UDI-DI
- 00810563023251 EUDAMED00816389020788 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 — 200 Millimeter FDA UDI
Category: General-purpose brachytherapy system applicator, remote-afterloading
Large sliding template, size 200 mm by Varian Medical Systems Deutschland GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
Similar devices
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 be334039-df93-4e2c-924c-2430b8cc5d3b 34 fields · synced Jul 24, 2026
- EUDAMED 03309dce-bf70-4657-a280-7ff1cd9d4519 61 fields · synced Jul 24, 2026