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Source guide tube light with locking mechanism for 200mm needles, GammaMedplus
EUDAMEDFDA UDIClass I (EU MDR)
Ref GM11007270
Identity
- Trade Name
- Source guide tube light with locking mechanism for 200mm needles, GammaMedplus EUDAMEDSource guide tube light with locking mechanism, 200 mm needles, GammaMedplus FDA UDI
- Generic Name
- Brachytherapy system remote afterloading source transfer tube FDA UDI
- Device Name
- Source Guide Tubes for Applicators and Needles EUDAMED
- Model / Reference
- GM11007270 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- GM11007270 FDA UDI
- Primary DI / UDI-DI
- 00816389024113 EUDAMEDFDA UDI
- Basic UDI-DI
- 089947500201052PV EUDAMED
- 510(k) Number
- K141336 FDA UDI
- FDA Product Code
- JAQ FDA UDI
- EMDN Code
- Z11010380 BRACHYTHERAPY RADIATION SYSTEMS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Brachytherapy system remote afterloading source transfer tube 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
Dimensions & Sizes
- Size
- Length — 200 Millimeter FDA UDI
Source guide tube light with locking mechanism for 200mm needles, GammaMedplus by Varian Medical Systems, Inc — Class I — MDR, FDA UDI — listed in EUDAMED…
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 089947500201052PV | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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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 fbf67055-4da0-42fd-93c2-e3a419f5664c 61 fields · synced Jul 22, 2026
- FDA UDI e245d5bf-a931-4b3b-9679-5a1a55ab398c 35 fields · synced May 27, 2026
- EUDAMED 136fd0c8-4a07-4e20-8d89-6cca6a3dd5a4 61 fields · synced Jul 22, 2026