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VariSource ClickFit Transfer Guide Tube Set
EUDAMEDFDA UDIClass I (EU MDR)
Ref GM19001000
Identity
- Trade Name
- VariSource ClickFit Transfer Guide Tube Set EUDAMEDFDA UDI
- Generic Name
- Brachytherapy system remote afterloading source transfer tube FDA UDI
- Device Name
- VariSource Reusable Transfer Guide Tubes – ClickFit EUDAMED
- Model / Reference
- GM19001000 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- GM19001000 FDA UDI
- Primary DI / UDI-DI
- 00816389026407 EUDAMEDFDA UDI
- Basic UDI-DI
- 089947500201022PL EUDAMED
- 510(k) Number
- K113766 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
Yes
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
VariSource ClickFit Transfer Guide Tube Set by Varian Medical Systems, Inc — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 089947500201022PL | 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 (2)
- EUDAMED e8eb6d6b-fce3-4562-9ac1-2e8f7fababbd 61 fields · synced Aug 2, 2026
- FDA UDI 8255a239-3589-4f1e-95a6-a937ba7c1777 34 fields · synced May 30, 2026