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GammaMed adjustable Luer source guide tube
EUDAMEDFDA UDIClass I (EU MDR)
Ref GM11008680
Identity
- Trade Name
- GammaMed adjustable Luer source guide tube EUDAMEDGammaMed adjustable Luer source guide tube, GammaMedplus or MammoSource FDA UDI
- Generic Name
- Vaginal brachytherapy system applicator, remote-afterloading FDA UDI
- Device Name
- GammaMed Adjustable Luer Source Guide Tube EUDAMED
- Model / Reference
- GM11008680 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- GM11008680 FDA UDI
- Primary DI / UDI-DI
- 00816389024694 EUDAMEDFDA UDI
- Basic UDI-DI
- 089947500201034PT 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
GammaMed adjustable Luer source guide tube by Varian Medical Systems, Inc — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 089947500201034PT | 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 8d8ba928-6b87-4e58-9f30-339915cd34d1 61 fields · synced Jul 26, 2026
- FDA UDI ac472529-b74b-4213-ae39-b3a3694fa54d 34 fields · synced May 29, 2026
- EUDAMED 1f1f0e5e-32fc-4305-895d-16e9017bff86 61 fields · synced Jul 26, 2026