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Source guide tube with locking mechanism for 113 mm needles, GammaMedplus
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref GM11000520510(k) K141336
Identity
- Trade Name
- Source guide tube with locking mechanism for 113 mm needles, GammaMedplus EUDAMEDFDA UDI
- Generic Name
- Brachytherapy system remote afterloading source transfer tube FDA UDI
- Device Name
- Source Guide Tubes for Applicators and Needles EUDAMED
- Model / Reference
- GM11000520 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- GM11000520 FDA UDI
- Primary DI / UDI-DI
- 00816389021570 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 — 113 Millimeter FDA UDI
Source guide tube with locking mechanism for 113 mm needles, GammaMedplus by Varian Medical Systems, Inc — Class I — FDA_510K, MDR — listed in EUDAMED, FDA…
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 | K141336 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 089947500201052PV | 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 (3)
- EUDAMED 52c8c702-0963-4161-bb2d-3801fa62617c 85 fields · synced Jun 18, 2026
- FDA UDI 41169e57-fcb1-4e0c-b2bf-aea403d8dd89 35 fields · synced May 30, 2026
- FDA 510(k) K141336 1 fields · synced May 18, 2026