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Source guide tube light with locking mechanism for 320 mm needles, GammaMedplus
EUDAMEDFDA UDIClass I (EU MDR)
Ref GM11010760
Identity
- Trade Name
- Source guide tube light with locking mechanism for 320 mm needles, GammaMedplus EUDAMEDFDA UDI
- Generic Name
- Vaginal brachytherapy system applicator, remote-afterloading FDA UDI
- Device Name
- Source Guide Tubes for Applicators and Needles EUDAMED
- Model / Reference
- GM11010760 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- GM11010760 FDA UDI
- Primary DI / UDI-DI
- 00816389025622 EUDAMEDFDA UDI
- Basic UDI-DI
- 089947500201052PV EUDAMED
- 510(k) Number
- K952913 FDA UDI
- FDA Product Code
- JAQ FDA UDI
- EMDN Code
- Z11010380 BRACHYTHERAPY RADIATION SYSTEMS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Vaginal brachytherapy system applicator, remote-afterloading 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
Moist Heat or Steam Sterilization FDA UDI
Source guide tube light with locking mechanism for 320 mm 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 f02ddfc6-edf6-40cc-a0ff-347760e16757 61 fields · synced Jul 15, 2026
- FDA UDI bfd062bf-1fed-4620-9ed0-5313a736288d 34 fields · synced May 30, 2026
- EUDAMED 5721114a-ca8e-4854-ad9e-790d2c60c58f 61 fields · synced Jul 15, 2026