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Source guide tube with locking mechanism for 320 mm interstitial implant tube, …
EUDAMEDFDA UDIClass I (EU MDR)
Ref GM11000310
Identity
- Trade Name
- Source guide tube with locking mechanism for 320 mm interstitial implant tube, GammaMedplus EUDAMEDSource guide tube with locking mechanism for 320 mm interstitial implant tubes FDA UDI
- Generic Name
- Brachytherapy system remote afterloading source transfer tube FDA UDI
- Device Name
- Source Guide Tubes for Interstitial Implant Tubes EUDAMED
- Model / Reference
- GM11000310 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- GM11000310 FDA UDI
- Primary DI / UDI-DI
- 00816389021464 EUDAMEDFDA UDI
- Basic UDI-DI
- 089947500201051PT 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 — 320 Millimeter FDA UDI
Source guide tube with locking mechanism for 320 mm interstitial implant tube, … 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 | 089947500201051PT | 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 ab525b71-af75-4c0d-9cdf-6db5a7ee3863 61 fields · synced Oct 6, 2026
- FDA UDI 54c3e7f9-b9df-451b-a17d-1fe11f79872f 35 fields · synced May 30, 2026
- EUDAMED 4e77217e-3534-41cd-8d7a-905a5c11a8d6 61 fields · synced Jul 16, 2026